recall_number string | recall_type string | firm_name string | product_description string | reason_for_recall string | status string | recall_class null | initiation_date date32 | report_date date32 | distribution_pattern string | product_quantity string | product_ndc string | fei_number string | facility_total_inspections float64 | facility_oai_count float64 | facility_last_classification string | facility_last_inspection date32 | facility_compliance_actions int64 | facility_warning_letters int64 | last_compliance_action_date date32 | preceded_by_oai bool | days_since_last_inspection float64 | failure_category string | failure_subcategory string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Z-1141-2022 | device | Baxter Healthcare Corporation | 15 Liters Drain Bag | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. | Ongoing | null | 2022-04-21 | 2022-06-08 | null | 510 units | null | 1025114 | 11 | 5 | Official Action Indicated (OAI) | 2024-02-09 | 0 | 0 | null | false | -1 | cGMP | unauthorized distribution |
Z-1837-2025 | device | Mckesson Medical-Surgical Inc. Corporate Office | ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result. | Ongoing | null | 2025-04-24 | 2025-06-04 | null | 60 units | null | null | null | null | null | null | 0 | 0 | null | false | null | stability | cold chain excursion |
Z-1079-2018 | device | Centurion Medical Products Corporation | SUTURE REMOVAL TRAY, SET or KIT | Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. | Terminated | null | 2017-10-23 | 2018-03-28 | null | N/A | null | null | null | null | null | null | 0 | 0 | null | false | null | potency | iodine assay deficient |
Z-2667-2024 | device | Alcon Research LLC | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Ophthalmic knife Component: N/A | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | Ongoing | null | 2024-07-15 | 2024-08-28 | null | 53,123 units | null | 1053053 | 6 | 0 | No Action Indicated (NAI) | 2021-08-24 | 0 | 0 | null | false | 0 | device_malfunction | reduced blade sharpness |
D-0574-2022 | drug | Pharmasol Corporation | Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302 | cGMP deviations | Terminated | null | 2022-01-11 | 2022-03-02 | Product was distributed to a client in Colorado. | 5,004 cans of propellent | null | 3014685473 | 1 | 1 | Official Action Indicated (OAI) | 2021-06-14 | 1 | 1 | 2019-03-14 | true | 0 | cGMP | GMP violations |
D-0240-2025 | drug | Glenmark Pharmaceuticals Inc., USA | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing | null | 2025-01-29 | 2025-02-26 | Nationwide within the U.S | 133,824 bottles | 16714-755 | 3005658103 | 3 | 0 | No Action Indicated (NAI) | 2016-12-05 | 3 | 3 | 2010-03-16 | false | 0 | cGMP | impurity above limit |
Z-0352-2026 | device | ICU Medical, Inc. | ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 | Port weld of drug transfer device may separate or break during use and potentially result in a leak. | Ongoing | null | 2025-09-08 | 2025-11-05 | null | 1700 units | null | 1713468 | 7 | 0 | No Action Indicated (NAI) | 2024-09-26 | 0 | 0 | null | false | 0 | device_malfunction | port weld separation |
Z-0712-2014 | device | Boston Scientific Corporation | Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140 | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size | Terminated | null | 2013-12-18 | 2014-01-22 | null | 34 units | null | 2124215 | 18 | 1 | Official Action Indicated (OAI) | 2025-04-07 | 0 | 0 | null | false | -1 | device_malfunction | incorrect dimensions |
Z-1868-2012 | device | Medical Components, Inc dba MedComp | MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit. | Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port. | Terminated | null | 2012-04-02 | 2012-07-04 | null | 30 | null | 2518902 | 6 | 0 | No Action Indicated (NAI) | 2021-09-23 | 1 | 1 | 2015-04-02 | false | -1 | mislabeling | incorrect port component |
Z-2192-2018 | device | Angiodynamics Inc. (Navilyst Medical Inc.) | Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Terminated | null | 2018-05-10 | 2018-06-20 | null | 17 boxes | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | bacterial endotoxins |
D-0739-2017 | drug | Key Pharmacy and Compounding Center | TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Terminated | null | 2017-04-18 | 2017-05-24 | Distributed nationwide in U.S.A., Australia and Canada. | 1 vial | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of sterility assurance |
Z-0207-2026 | device | Cardinal Health 200, LLC | Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm) 5558264957 ... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214. | Ongoing | null | 2025-09-18 | 2025-10-29 | null | all lots | null | 3002973487 | 3 | 0 | No Action Indicated (NAI) | 2015-07-20 | 0 | 0 | null | false | 0 | device_malfunction | valve breakage excessive force |
Z-1305-2013 | device | Karl Storz Endoscopy America Inc | Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). | Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. | Terminated | null | 2009-06-01 | 2013-05-22 | null | 9432 units | null | 2020550 | 5 | 0 | Voluntary Action Indicated (VAI) | 2024-02-15 | 0 | 0 | null | false | -1 | sterility | damaged sterile packaging |
D-0440-2024 | drug | Eugia US LLC | Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10 | Presence of Particulate Matter | Ongoing | null | 2024-02-15 | 2024-04-17 | Nationwide in the USA | 1,552 10ml x 25/carton | 55150-223 | null | null | null | null | null | 0 | 0 | null | false | null | foreign_material | particulate matter |
Z-1764-2018 | device | Bard Peripheral Vascular Inc | POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300 | The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. | Completed | null | 2018-02-08 | 2018-05-16 | null | 2835 units | null | 2020394 | 11 | 1 | No Action Indicated (NAI) | 2024-03-08 | 1 | 1 | 2015-07-13 | false | -1 | mislabeling | incorrect instructions |
D-0782-2017 | drug | Key Pharmacy and Compounding Center | TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Terminated | null | 2017-04-18 | 2017-05-24 | Distributed nationwide in U.S.A., Australia and Canada. | 2 vials | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of sterility assurance |
D-1036-2018 | drug | Baxter Healthcare Corporation | Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24. | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Terminated | null | 2018-08-01 | 2018-08-15 | Nationwide USA and Puerto Rico | 711,216 bags | 36000-045 | 1417572 | 11 | 1 | No Action Indicated (NAI) | 2024-02-06 | 1 | 1 | 2009-09-10 | false | -1 | potency | superpotent API |
Z-2083-2014 | device | DePuy Orthopaedics, Inc. | RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation. | The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. | Terminated | null | 2014-06-03 | 2014-07-30 | null | 10,467 units | null | 3005572635 | 1 | 0 | No Action Indicated (NAI) | 2009-01-12 | 0 | 0 | null | false | 0 | device_malfunction | difficult removal |
Z-2515-2021 | device | Aesculap Implant Systems LLC | Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z AS UN... | Malfunction- loosening of the implant resulting in a potential revision surgery | Terminated | null | 2021-03-19 | 2021-09-29 | null | null | 3005739625 | 4 | 0 | No Action Indicated (NAI) | 2023-11-09 | 0 | 0 | null | false | -1 | device_malfunction | implant loosening | |
Z-1043-2022 | device | Medtronic Vascular, Inc. | Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. | Ongoing | null | 2022-03-23 | 2022-05-18 | null | 3 units | null | 3005364322 | 5 | 0 | No Action Indicated (NAI) | 2017-09-08 | 0 | 0 | null | false | 0 | packaging | damaged sterile barrier |
Z-2765-2020 | device | Boston Scientific Corporation | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and re... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhag... | Ongoing | null | 2020-07-06 | 2020-08-12 | null | null | 2183460 | 6 | 0 | No Action Indicated (NAI) | 2016-02-24 | 0 | 0 | null | false | 0 | device_malfunction | snare cutting failure | |
Z-0197-2022 | device | Implant Direct Sybron Manufacturing LLC | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Ongoing | null | 2021-09-23 | 2021-11-10 | null | 61 implants | null | 3021086939 | 1 | 0 | No Action Indicated (NAI) | 2025-04-02 | 0 | 0 | null | false | -1 | mislabeling | incorrect size declared |
Z-2210-2023 | device | Cytocell Ltd. | RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome. | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. | Ongoing | null | 2023-05-24 | 2023-07-26 | null | 61 units | null | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | inverted DNAs manufacturing |
Z-0697-2014 | device | ICU Medical, Inc. | 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient thr... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. | Terminated | null | 2013-12-24 | 2014-01-15 | null | 500 units | null | 1713468 | 7 | 0 | No Action Indicated (NAI) | 2024-09-26 | 0 | 0 | null | false | -1 | device_malfunction | connector leakage |
Z-0503-2017 | device | ICU Medical, Inc. | MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a comp... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Terminated | null | 2016-09-27 | 2016-11-23 | null | 20 units | null | 1713468 | 7 | 0 | No Action Indicated (NAI) | 2024-09-26 | 0 | 0 | null | false | -1 | device_malfunction | potential leak |
D-0154-2017 | drug | Par Pharmaceutical, Inc. | Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977 | Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container | Terminated | null | 2016-10-05 | 2016-12-07 | Nationwide | a) 182,856 bottles; b) 59,448 bottles | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | dropper tip damage |
D-0336-2025 | drug | Glenmark Pharmaceuticals Inc., USA | Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05. | CGMP Deviations | Ongoing | null | 2025-03-13 | 2025-04-16 | U.S. Nationwide | N/A | 68462-162 | 3005658103 | 3 | 0 | No Action Indicated (NAI) | 2016-12-05 | 3 | 3 | 2010-03-16 | false | 0 | cGMP | manufacturing deviations |
Z-2254-2017 | device | Arrow International Inc | ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. T... | Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products. | Terminated | null | 2017-03-20 | 2017-06-14 | null | unknown-firm reports total devices distributed 43,394 eaches | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | safety cover disengagement |
D-0542-2021 | drug | Cardinal Health Inc. | Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo Allegan, MI 49010 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 5 tubes | 45802-101 | 1000148701 | 3 | 0 | No Action Indicated (NAI) | 2020-02-19 | 0 | 0 | null | false | 0 | cGMP | temperature excursion |
Z-1283-2019 | device | Cardinal Health 200, LLC | ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap | Terminated | null | 2019-03-22 | 2019-05-15 | null | 11588 | null | 3004335638 | 2 | 0 | No Action Indicated (NAI) | 2022-06-27 | 0 | 0 | null | false | -1 | mislabeling | latex content claim |
D-1485-2015 | drug | The Compounding Pharmacy of America | Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Terminated | null | 2015-06-02 | 2015-09-23 | Nationwide | 44 ml total volume | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | GMP violations |
D-1395-2016 | drug | Pharmedium Services, LLC | 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC 61553-201-54 , 200 ml in 250 ml Hospira LifeCare Bag... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Terminated | null | 2016-05-05 | 2016-07-27 | Nationwide | 43,589 bags | null | 3000717703 | 4 | 3 | Official Action Indicated (OAI) | 2017-12-22 | 1 | 1 | 2014-07-18 | false | -1 | contamination | glass particulate matter |
Z-1416-2014 | device | LumiQuick Diagnostics Inc. | CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Terminated | null | 2014-03-04 | 2014-04-16 | null | ALL | null | 3005984081 | 5 | 1 | No Action Indicated (NAI) | 2025-11-05 | 2 | 2 | 2014-04-01 | false | -1 | other | unapproved device distribution |
Z-0473-2026 | device | Medline Industries, LP | Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. | Ongoing | null | 2025-10-01 | 2025-11-19 | null | 60,917 units | null | 3008367578 | 1 | 0 | No Action Indicated (NAI) | 2023-12-13 | 0 | 0 | null | false | 0 | device_malfunction | material trapping defect |
Z-1910-2016 | device | Stryker Corporation | Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures. | Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction | Terminated | null | 2016-05-04 | 2016-06-15 | null | 21 units | null | 2936485 | 7 | 0 | Voluntary Action Indicated (VAI) | 2019-11-21 | 0 | 0 | null | false | -1 | device_malfunction | incorrect assembly orientation |
D-0858-2020 | drug | Contract Pharmacal Corporation | Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle. | Terminated | null | 2020-02-03 | 2020-02-19 | Nationwide within the United States | a) 1176 bottles b) 6,216 bottles | 0904-6730 | 2427358 | 15 | 1 | Voluntary Action Indicated (VAI) | 2022-04-14 | 1 | 1 | 2010-10-14 | false | -1 | foreign_material | wrong product commingled |
D-0148-2026 | drug | SUN PHARMACEUTICAL INDUSTRIES INC | Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88. | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | Ongoing | null | 2025-10-28 | 2025-11-05 | U.S Nationwide. | N/A | 57664-046 | 3028772083 | 1 | 0 | No Action Indicated (NAI) | 2024-02-15 | 0 | 0 | null | false | 0 | stability | failed dissolution test |
Z-1567-2025 | device | Baxter Healthcare Corporation | Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11,... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. | Ongoing | null | 2025-03-21 | 2025-04-23 | null | 385920 units | null | 1417572 | 11 | 1 | No Action Indicated (NAI) | 2024-02-06 | 1 | 1 | 2009-09-10 | false | 0 | foreign_material | rubber band contamination |
Z-0041-2015 | device | Smith & Nephew, Inc. | RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | Terminated | null | 2014-07-18 | 2014-10-15 | null | 45,466 | null | 3006760724 | 4 | 1 | Voluntary Action Indicated (VAI) | 2015-01-13 | 1 | 1 | 2014-06-11 | false | -1 | device_malfunction | inlet port deformation |
Z-0821-2013 | device | Viterion TeleHealthcare Llc | Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information. | Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals. | Terminated | null | 2012-11-15 | 2013-02-20 | null | Domestic - 7698 units | null | 3003962513 | 2 | 0 | Voluntary Action Indicated (VAI) | 2013-06-28 | 0 | 0 | null | false | -1 | software | data transmission error |
D-678-2014 | drug | Aidapak Services, LLC | METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304057901 | Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD22845_1, EXP: 4/30/2014; LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD73525_49, EXP: 5/30/2014. | Terminated | null | 2013-07-02 | 2014-01-22 | Repacked drugs were distributed in Arizona, California, Oregon, and Washington. | 420 Tablets | null | 3008673824 | 3 | 0 | Voluntary Action Indicated (VAI) | 2013-07-31 | 0 | 0 | null | false | -1 | mislabeling | label mixup |
Z-0941-2024 | device | Olympus Corporation of the Americas | EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355 | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. | Ongoing | null | 2023-11-10 | 2024-02-07 | null | 3354 units | null | 1000635022 | 4 | 0 | Voluntary Action Indicated (VAI) | 2022-03-10 | 1 | 1 | 2015-08-12 | false | 0 | device_malfunction | balloon integrity failure |
D-0938-2020 | drug | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2 | Lack of Assurance of Sterility | Terminated | null | 2020-01-15 | 2020-03-11 | U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic | N/A | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | sterility assurance failure |
Z-0852-2024 | device | Cardinal Health 200, LLC | Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to ... | Ongoing | null | 2023-12-28 | 2024-02-14 | null | null | 3034315018 | 1 | 0 | No Action Indicated (NAI) | 2025-09-18 | 0 | 0 | null | false | -1 | device_malfunction | manufacturing change impact | |
Z-0163-2025 | device | MEDLINE INDUSTRIES, LP - Northfield | Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. | Ongoing | null | 2024-09-04 | 2024-10-30 | null | 90 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | breather pouch seal failure |
Z-2169-2020 | device | American Contract Systems | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Terminated | null | 2020-04-13 | 2020-06-10 | null | 2, 868 total kits | null | 3011389083 | 5 | 1 | No Action Indicated (NAI) | 2022-03-25 | 1 | 1 | 2018-11-06 | false | -1 | cGMP | unregistered facility |
D-0627-2017 | drug | Alvogen, Inc | Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01. | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Terminated | null | 2017-03-07 | 2017-04-12 | Nationwide | N/A | null | 3008454186 | 5 | 0 | No Action Indicated (NAI) | 2024-11-21 | 0 | 0 | null | false | -1 | contamination | cross-contamination sorafenib |
Z-1291-2020 | device | Covidien LLC | Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | Terminated | null | 2019-12-18 | 2020-02-26 | null | 139,938 units total | null | 1221611 | 1 | 0 | No Action Indicated (NAI) | 2010-11-30 | 0 | 0 | null | false | 0 | packaging | integrity barrier failure |
D-0727-2019 | drug | King Bio Inc. | Dr. King's SafeCare Rx Asthma Clear Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004424, NDC 57955-0044-2 | Microbial contamination | Terminated | null | 2018-07-20 | 2019-03-20 | U.S.A. Nationwide, Canada, and Australia. | 797 bottles | null | 1053442 | 8 | 1 | Voluntary Action Indicated (VAI) | 2023-07-28 | 2 | 2 | 2019-03-20 | false | -1 | contamination | microbial contamination |
D-0024-2024 | drug | Central Admixture Pharmacy Services Inc | fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2 | Lack of assurance of sterility: | Terminated | null | 2023-09-21 | 2023-10-11 | Nationwide in the USA | 962 30 mL syringes. | null | 3004378804 | 2 | 1 | Voluntary Action Indicated (VAI) | 2018-09-11 | 2 | 2 | 2024-07-11 | false | 0 | sterility | sterility assurance failure |
Z-1572-2016 | device | Siemens Medical Solutions USA, Inc. | ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applica... | Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to recover system operation. | Terminated | null | 2015-09-05 | 2016-05-04 | null | 4 | null | 1000514697 | 3 | 0 | No Action Indicated (NAI) | 2019-06-10 | 0 | 0 | null | false | -1 | software | transducer communication error |
Z-0952-2018 | device | Cook Inc. | Bentson Plus Wire Guide | Label does not state that the product is heparin-coated. | Terminated | null | 2017-10-13 | 2018-03-21 | null | 8,147 | null | null | null | null | null | null | 0 | 0 | null | false | null | mislabeling | missing heparin coating statement |
D-1034-2015 | drug | Health Innovations Pharmacy, Inc | Nortriptyline 10 mg/5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155 | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Terminated | null | 2015-02-12 | 2015-05-20 | NC | One Rx | null | 3011364861 | 2 | 1 | No Action Indicated (NAI) | 2017-08-02 | 1 | 1 | 2016-07-08 | false | -1 | sterility | stability data inadequate |
D-1022-2013 | drug | University Compounding Pharmacy | Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. | Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns. | Terminated | null | 2013-09-06 | 2013-09-18 | Nationwide | 70 mL | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of sterility assurance |
Z-0358-2023 | device | Cardinal Health | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention | Ongoing | null | 2022-11-01 | 2022-12-14 | null | N/A | null | 2129617 | 1 | 0 | No Action Indicated (NAI) | 2011-07-20 | 0 | 0 | null | false | 0 | device_malfunction | bubble inlet port occlusion |
D-782-2013 | drug | Lowlite Investments, Inc. D/B/A Olympia Pharmacy | Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Ongoing | null | 2013-05-29 | 2013-07-17 | Nationwide and PR | 10 | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | QC process deficiency |
Z-1408-2015 | device | VasoNova, Inc. | VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. | A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1. | Terminated | null | 2015-03-30 | 2015-04-15 | null | 17 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | IEC standard noncompliance |
Z-1853-2019 | device | Maquet Cardiovascular Us Sales, Llc | Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | Terminated | null | 2019-05-28 | 2019-07-03 | null | 11 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | cracked light head coating |
D-1655-2015 | drug | The Compounding Pharmacy of America | Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Terminated | null | 2015-06-02 | 2015-09-23 | Nationwide | 192 pellets | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | GMP violations |
D-0129-2019 | drug | Teva Pharmaceuticals USA | Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01 | Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing. | Terminated | null | 2018-10-19 | 2018-10-31 | U.S.A. Nationwide including Puerto Rico. | 53,451 bottles | null | null | null | null | null | null | 0 | 0 | null | false | null | stability | failed dissolution |
Z-0031-2023 | device | Hobbs Medical, Inc. | Hobbs Helical Retrieval Basket Catalog Number: 4824 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ... | Ongoing | null | 2022-07-29 | 2022-10-19 | null | 10 units | null | 1220592 | 5 | 0 | Voluntary Action Indicated (VAI) | 2021-08-27 | 0 | 0 | null | false | 0 | mislabeling | incorrect expiration date |
D-0403-2018 | drug | Sage Products Inc | Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcoh... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Terminated | null | 2017-08-22 | 2018-02-21 | Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand | 480 Cases | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | cross contamination |
D-1284-2014 | drug | Caraco Pharmaceutical Laboratories, Ltd. | Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactu... | Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. | Terminated | null | 2014-03-20 | 2014-05-07 | Nationwide and Puerto Rico | 91,777 bottles | null | 3006389940 | 1 | 0 | Voluntary Action Indicated (VAI) | 2008-12-22 | 0 | 0 | null | false | 0 | stability | failed dissolution |
D-1159-2015 | drug | Lincare, Inc. | TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, MgSO4, KCL, NaC, Zinc Cl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 So... | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | 7 Bags | null | 1000307060 | 1 | 0 | Voluntary Action Indicated (VAI) | 2010-09-22 | 0 | 0 | null | false | 0 | sterility | lack of sterility assurance |
Z-0069-2017 | device | Cardinal Health 200, LLC | V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX. | Potential risk associated with corrosion demonstrated on the distraction screw surface. | Terminated | null | 2016-09-23 | 2016-10-19 | null | 72,076 units | null | 3001236905 | 4 | 1 | Official Action Indicated (OAI) | 2023-12-20 | 1 | 1 | 2024-04-24 | false | -1 | device_malfunction | screw corrosion |
D-207-2014 | drug | Main Street Family Pharmacy, LLC | Methylcobalamin 1mg/ml 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Terminated | null | 2013-05-28 | 2013-12-11 | nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV | 265 units | null | 3010199183 | 1 | 1 | Official Action Indicated (OAI) | 2013-06-11 | 0 | 0 | null | false | -1 | sterility | microbial contamination |
Z-3197-2017 | device | Zimmer Biomet, Inc. | Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical instrument. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | Terminated | null | 2017-05-22 | 2017-10-04 | null | 236 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | material defect fracture risk |
Z-0703-2019 | device | GE Healthcare, LLC | Discover VH/Millennium VG Nuclear Medicine Imaging System | A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan. | Completed | null | 2017-10-30 | 2019-01-16 | null | 339 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | collimator lock failure |
Z-1312-2023 | device | Defibtech, LLC | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest | A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy. | Ongoing | null | 2023-02-14 | 2023-04-05 | null | 29 units | null | 3012972516 | 2 | 0 | Voluntary Action Indicated (VAI) | 2025-03-25 | 0 | 0 | null | false | -1 | device_malfunction | untested component failure |
D-811-2014 | drug | Aidapak Services, LLC | LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074707090. | Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 60 mg, NDC 55513007430, Pedigree: W003742, EXP: 6/26/2014. | Terminated | null | 2013-07-02 | 2014-01-29 | Repacked drugs were distributed in Arizona, California, Oregon, and Washington. | 90 Tablets | null | 3008673824 | 3 | 0 | Voluntary Action Indicated (VAI) | 2013-07-31 | 0 | 0 | null | false | -1 | mislabeling | label mixup |
D-0232-2026 | drug | Novocol Pharmaceutical of Canada, Inc. | Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., ND... | Defective container: cracked/broken cartridges | Ongoing | null | 2025-10-31 | 2025-12-24 | U.S.A. Nationwide | 66975-406 | 3002807757 | 10 | 0 | Voluntary Action Indicated (VAI) | 2024-05-03 | 0 | 0 | null | false | 0 | packaging | cracked cartridges | |
D-1077-2018 | drug | Lupin Pharmaceuticals Inc. | Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03 | Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet. | Terminated | null | 2018-08-13 | 2018-08-22 | Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States. | 11,706 bottles | 68180-512 | 3004097115 | 4 | 0 | Voluntary Action Indicated (VAI) | 2014-05-23 | 0 | 0 | null | false | 0 | foreign_material | metal in tablet |
D-0753-2023 | drug | Central Admixture Pharmacy Services, Inc. | Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Terminated | null | 2023-04-28 | 2023-05-31 | Nationwide in the USA. | 1516 bags | null | 3004407863 | 1 | 1 | Official Action Indicated (OAI) | 2014-02-20 | 0 | 0 | null | true | 0 | sterility | sterility assurance failure |
Z-2132-2017 | device | Cardinal Health 200, LLC | Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or duc... | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | Terminated | null | 2017-04-21 | 2017-05-31 | null | null | 3004335638 | 2 | 0 | No Action Indicated (NAI) | 2022-06-27 | 0 | 0 | null | false | -1 | sterility | compromised seal | |
D-1074-2022 | drug | Mckesson Medical-Surgical Inc. Corporate Office | MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), 5 mL multi-dose vials, Rx only, MFG: Teva Pharma USA, NDC 0703-0063-01 | cGMP deviations: Temperature abuse | Terminated | null | 2022-04-13 | 2022-06-15 | USA nationwide. | 816 cartons/1 vial each | null | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | temperature abuse |
D-0525-2021 | drug | Cardinal Health Inc. | ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 122 inhalers | null | 3004008697 | 5 | 0 | No Action Indicated (NAI) | 2017-09-12 | 0 | 0 | null | false | 0 | cGMP | temperature excursion |
Z-1817-2015 | device | Boston Scientific Corporation | CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, cat... | Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become over-written to a variable degree, with the result that it appears shifted from baseline on the system's output screen. This may, in t... | Terminated | null | 2015-06-02 | 2015-06-24 | null | 43 units | null | 3003882783 | 1 | 0 | No Action Indicated (NAI) | 2018-08-30 | 0 | 0 | null | false | -1 | software | ECG signal corruption |
D-1463-2019 | drug | Golden State Medical Supply Inc. | Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Terminated | null | 2019-06-14 | 2019-07-17 | US Nationwide One (1) US government account. No foreign accounts. | 14,955 bottles (1,345,950 tablets) | null | 3006458969 | 10 | 1 | No Action Indicated (NAI) | 2025-06-11 | 1 | 1 | 2011-04-26 | false | -1 | cGMP | NMBA impurity detection |
Z-1089-2026 | device | Medline Industries, LP | Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYN... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemb... | Ongoing | null | 2025-12-16 | 2026-01-21 | null | 1457 units | null | 3011508621 | 1 | 0 | Voluntary Action Indicated (VAI) | 2018-05-25 | 0 | 0 | null | false | 0 | device_malfunction | liquid leakage design defect |
Z-2741-2015 | device | Siemens Healthcare Diagnostics, Inc. | Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine. | Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively. | Terminated | null | 2015-07-15 | 2015-09-16 | null | Total number Dimension Vista - 32,165, Dimension - 238,634 | null | 2517506 | 4 | 1 | Voluntary Action Indicated (VAI) | 2014-04-23 | 1 | 1 | 2012-06-29 | false | 0 | device_malfunction | falsely depressed results |
D-1081-2019 | drug | RemedyRepack Inc. | Losartan 50mg Tablet, 30 count each blister card. | CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA). | Terminated | null | 2019-03-14 | 2019-04-17 | Product was distributed to one sole customer, Miami, FL. | 33 blister cards of 30 = 990 tablets | null | 3005841768 | 5 | 1 | Official Action Indicated (OAI) | 2022-11-10 | 2 | 2 | 2023-05-11 | false | -1 | cGMP | unexpected API impurity |
Z-1330-2019 | device | Shippert Medical Technologies | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. | Completed | null | 2018-02-02 | 2019-05-22 | null | 6,553 units were distributed for all catalog numbers | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | pouch integrity compromise |
Z-1476-2024 | device | Abbott Laboratories | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction. | Ongoing | null | 2024-02-21 | 2024-04-10 | null | 7482 kits | null | 1415939 | 16 | 0 | No Action Indicated (NAI) | 2024-05-29 | 2 | 2 | 2023-10-24 | false | -1 | device_malfunction | calibration failure |
Z-1035-2020 | device | Cardinal Health | AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. | Terminated | null | 2020-01-11 | 2020-02-12 | null | 7,659,634 total units | null | 3010509533 | 1 | 0 | No Action Indicated (NAI) | 2015-04-28 | 0 | 0 | null | false | 0 | contamination | bioburden and particulates |
Z-0299-2017 | device | Keystone Dental Inc | Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations ... | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) | Terminated | null | 2016-09-15 | 2016-11-02 | null | 55 units | null | 3005990499 | 3 | 0 | Voluntary Action Indicated (VAI) | 2017-06-08 | 0 | 0 | null | false | -1 | packaging | wrong component included |
Z-0885-2023 | device | Datascope Corp. | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-33, 0998-UC-0800-34,... | The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter. | Ongoing | null | 2022-12-19 | 2023-01-25 | null | 11,906 Total | null | 3009540546 | 1 | 1 | Official Action Indicated (OAI) | 2013-10-17 | 0 | 0 | null | true | 0 | device_malfunction | unexpected shutdown |
D-0023-2024 | drug | Central Admixture Pharmacy Services Inc | fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5 | Lack of assurance of sterility: | Terminated | null | 2023-09-21 | 2023-10-11 | Nationwide in the USA | 71 100 mL bags | null | 3003693389 | 1 | 0 | Voluntary Action Indicated (VAI) | 2016-01-21 | 0 | 0 | null | false | 0 | sterility | sterility assurance failure |
D-1629-2019 | drug | Herbal Doctor Remedies | Fungo Off Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Terminated | null | 2019-07-12 | 2019-08-14 | Nationwide within the United States and Brazil and on the internet | N/A | null | 3003040962 | 3 | 1 | No Action Indicated (NAI) | 2018-05-22 | 2 | 2 | 2019-10-04 | false | 0 | cGMP | manufacturing controls |
D-460-2015 | drug | Central Admixture Pharmacy Services, Inc. | Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 200mg/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; C... | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Terminated | null | 2014-12-17 | 2015-04-15 | Nationwide | 20 bags | null | 1000307034 | 2 | 0 | Voluntary Action Indicated (VAI) | 2015-11-20 | 0 | 0 | null | false | -1 | sterility | microbial contamination |
Z-1046-2025 | device | GE Medical Systems, LLC | Optima XR646 HD. X-Ray imaging system. | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached. | Ongoing | null | 2025-01-28 | 2025-02-12 | null | 3149 (1697 US; 1452 OUS) | null | 2183553 | 3 | 0 | No Action Indicated (NAI) | 2012-10-11 | 0 | 0 | null | false | 0 | software | AEC limit logic |
D-1551-2015 | drug | The Compounding Pharmacy of America | Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Terminated | null | 2015-06-02 | 2015-09-23 | Nationwide | 43 ml total | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | GMP violations |
D-600-2013 | drug | OLAAX International | MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL | Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug. | Terminated | null | 2013-02-12 | 2013-06-19 | Nationwide, Puerto Rico and Venezuela and Bolivia | 600 boxes | null | null | null | null | null | null | 0 | 0 | null | false | null | other | unapproved new drug |
D-0078-2018 | drug | Allergan Sales, LLC | Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03 | Failed Impurities/Degradation Specifications. | Terminated | null | 2017-10-19 | 2017-11-22 | Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago. | 153,616 bottles | 0023-3205 | 3000720089 | 5 | 0 | No Action Indicated (NAI) | 2024-09-03 | 0 | 0 | null | false | -1 | potency | impurity degradation |
Z-1886-2012 | device | Terumo Cardiovascular Systems Corporation | X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance wa... | Terminated | null | 2012-05-09 | 2012-07-04 | null | 53,139 (each) in total | null | 1828100 | 10 | 2 | No Action Indicated (NAI) | 2021-07-14 | 1 | 0 | 2011-03-29 | false | -1 | foreign_material | molding residue |
Z-2304-2016 | device | Roche Diagnostics Operations, Inc. | ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. | Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer. | Terminated | null | 2016-05-26 | 2016-08-10 | null | 53,897 Units distributed | null | 1823260 | 9 | 0 | No Action Indicated (NAI) | 2022-12-07 | 0 | 0 | null | false | -1 | software | incorrect method comparison |
D-1496-2020 | drug | Taro Pharmaceuticals U.S.A., Inc. | Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012. | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. | Terminated | null | 2020-07-20 | 2020-08-19 | Nationwide in the U.S. | 7632 tubes | null | 2435212 | 5 | 0 | No Action Indicated (NAI) | 2018-08-27 | 0 | 0 | null | false | 0 | potency | failed content uniformity |
Z-0696-2020 | device | Smith & Nephew, Inc. | smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery. | There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip ... | Terminated | null | 2019-11-11 | 2019-12-25 | null | 1371 devices | null | 3007282753 | 2 | 0 | No Action Indicated (NAI) | 2017-07-24 | 0 | 0 | null | false | 0 | device_malfunction | mallet tip detachment |
D-1172-2018 | drug | Mckesson Corporation | Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51 | Supterpotent Drug | Terminated | null | 2018-08-14 | 2018-09-12 | Nationwide within the United States | 1531 cartons | null | 2015316 | 3 | 0 | No Action Indicated (NAI) | 2024-07-09 | 0 | 0 | null | false | -1 | potency | superpotent API |
D-0858-2017 | drug | Strides Pharma INC | Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06 | Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content. | Terminated | null | 2017-05-09 | 2017-05-31 | U.S.A. Nationwide | 127,517 bottles | 64380-712 | null | null | null | null | null | 0 | 0 | null | false | null | stability | preservative degradation |
Z-1011-2020 | device | Cardinal Health | AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. | Terminated | null | 2020-01-11 | 2020-02-12 | null | 7,659,634 total units | null | 3011200334 | 1 | 0 | No Action Indicated (NAI) | 2017-01-25 | 0 | 0 | null | false | 0 | contamination | bioburden and particulates |
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