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-0466-2024 | device | Staar Surgical Company | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Ongoing | null | 2023-09-29 | 2023-12-13 | null | 51 units | null | 2023826 | 7 | 2 | Voluntary Action Indicated (VAI) | 2018-05-18 | 1 | 1 | 2014-05-21 | false | 0 | device_malfunction | specification non-conformance |
Z-2670-2025 | device | Medline Industries, LP | Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q | The kits contain certain lots of cannula products where the catheter may not retain its shape. | Ongoing | null | 2025-08-21 | 2025-10-08 | null | 828 units | null | 3010933851 | 1 | 0 | No Action Indicated (NAI) | 2023-07-13 | 0 | 0 | null | false | 0 | device_malfunction | catheter shape retention |
Z-1552-2020 | device | QUIDEL CARDIOVASCULAR INC | Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com | Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail. | Terminated | null | 2019-04-09 | 2020-04-01 | null | 123 kits | null | null | null | null | null | null | 0 | 0 | null | false | null | software | control display error |
D-462-2014 | drug | Mariposa Labs, LLC | NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201 | Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications. | Terminated | null | 2012-11-29 | 2014-01-22 | One consignee who in turn sent it to one consignee | 14,664 tubes | null | 3004003370 | 1 | 0 | Voluntary Action Indicated (VAI) | 2013-11-22 | 1 | 1 | 2019-03-14 | false | -1 | contamination | microbial contamination |
D-1205-2015 | drug | Lincare, Inc. | Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | 7 Syringes | null | 3000718901 | 1 | 0 | No Action Indicated (NAI) | 2011-11-08 | 0 | 0 | null | false | 0 | sterility | unassured sterility |
Z-2605-2017 | device | Medtronic Inc. | MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760. | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. | Terminated | null | 2017-05-08 | 2017-06-28 | null | 117,239 pumps | null | 3008786301 | 2 | 0 | No Action Indicated (NAI) | 2015-03-10 | 0 | 0 | null | false | 0 | device_malfunction | pump malfunction |
D-0484-2016 | drug | Western Drug | Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Terminated | null | 2015-10-19 | 2015-12-09 | Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah | 1 container | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of sterility assurance |
Z-0934-2024 | device | Olympus Corporation of the Americas | EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080 | 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 | 1796 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-0815-2018 | drug | Pharmalucence, Inc. | Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821. | Failed Stability Specifications | Terminated | null | 2018-04-10 | 2018-05-23 | US Nationwide | 157 units (5 count) and 464 units (30 count) | 45567-0455 | null | null | null | null | null | 0 | 0 | null | false | null | stability | failed stability testing |
D-0228-2016 | drug | the Compounder | TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | Terminated | null | 2015-03-10 | 2015-11-18 | Nationwide | 60 capsules | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | penicillin cross-contamination |
Z-1336-2024 | device | Angiodynamics, Inc. | MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751 | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the... | Ongoing | null | 2024-01-30 | 2024-03-27 | null | 959 units | null | 1319211 | 7 | 3 | Voluntary Action Indicated (VAI) | 2025-01-10 | 2 | 2 | 2011-05-27 | false | -1 | device_malfunction | lumen obstruction voids |
D-0388-2024 | drug | Micro Labs Limited | Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30. | Failed Stability Specifications: Out of specification for blend uniformity. | Terminated | null | 2024-02-09 | 2024-03-20 | Puerto Rico, TN, RI | 118,080 bottles | 42571-226 | 3005210225 | 6 | 1 | Voluntary Action Indicated (VAI) | 2025-05-30 | 1 | 1 | 2015-01-09 | false | -1 | stability | blend uniformity |
D-0681-2016 | drug | Abbott's Compounding Pharmacy, Inc. | Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Terminated | null | 2016-01-15 | 2016-02-24 | CA | 90 ml | null | 3005529620 | 1 | 1 | Official Action Indicated (OAI) | 2016-01-08 | 1 | 1 | 2017-04-04 | true | 0 | sterility | lack of assurance |
Z-0779-2021 | device | Medline Industries Inc | Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries. | The cylindrical sponge component is not x-ray detectable. | Terminated | null | 2020-11-13 | 2021-01-13 | null | 88 | null | 3003650777 | 1 | 0 | No Action Indicated (NAI) | 2019-04-17 | 0 | 0 | null | false | 0 | device_malfunction | non-detectable component |
Z-0751-2019 | device | Kimberly-Clark Corporation | U by Kotex¿ Sleek¿, Regular Tampons, 3 Count | Potential for tampon to come apart upon removal. | Terminated | null | 2018-12-11 | 2019-01-23 | null | 68,852,076 units total | null | 3003701733 | 3 | 0 | Voluntary Action Indicated (VAI) | 2019-07-25 | 0 | 0 | null | false | -1 | device_malfunction | disintegration upon removal |
D-0018-2022 | drug | Sanitor Corporation | Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3 | CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues. | Terminated | null | 2021-09-21 | 2021-10-27 | Distributed to one distributor located in Las Vegas, NV. | unknown | null | 3005871025 | 8 | 2 | No Action Indicated (NAI) | 2024-08-20 | 1 | 1 | 2021-11-29 | false | -1 | cGMP | manufacturing deviation |
Z-2678-2020 | device | Boston Scientific Corporation | Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. | The needle surface deteriorated due to unexpected electrolysis during procedure. | Terminated | null | 2020-06-04 | 2020-07-29 | null | 79 devices | null | 3001236349 | 8 | 0 | No Action Indicated (NAI) | 2019-09-25 | 0 | 0 | null | false | 0 | device_malfunction | needle surface deterioration |
D-0609-2023 | drug | Astral SteriTech Private Ltd. | Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02 | Lack of Assurance of Sterility | Terminated | null | 2023-05-15 | 2023-05-24 | Nationwide within the United States | 550,160 vials | null | 3005508230 | 5 | 1 | Official Action Indicated (OAI) | 2023-06-20 | 0 | 0 | null | false | -1 | sterility | sterility assurance failure |
D-0988-2020 | drug | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical | Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1 | 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 | lack of assurance |
D-1361-2015 | drug | GlaxoSmithKline, LLC. | Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | Terminated | null | 2015-08-13 | 2015-09-02 | Nationwide and Puerto Rico | 28,480 tubes of 15g, 12,234 tubes of 30g | null | 3004055938 | 4 | 0 | No Action Indicated (NAI) | 2023-06-20 | 0 | 0 | null | false | -1 | contamination | penicillin cross-contamination |
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 | 3002973487 | 3 | 0 | No Action Indicated (NAI) | 2015-07-20 | 0 | 0 | null | false | 0 | device_malfunction | screw corrosion |
Z-1098-2019 | device | ICU Medical, Inc. | SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug ... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device. | Terminated | null | 2019-02-21 | 2019-04-24 | null | 3500 units | null | 3013319212 | 8 | 2 | No Action Indicated (NAI) | 2024-09-09 | 2 | 2 | 2013-05-09 | false | -1 | foreign_material | plastic burr particulate |
Z-0685-2021 | device | Boston Scientific Corporation | Three IcePearl" 2.1 CX Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Completed | null | 2020-11-18 | 2020-12-30 | null | 117 units | null | 3003882783 | 1 | 0 | No Action Indicated (NAI) | 2018-08-30 | 0 | 0 | null | false | 0 | device_malfunction | needle gas leak |
Z-0865-2017 | device | Accuray Incorporated | CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. | Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System. | Terminated | null | 2016-12-06 | 2016-12-28 | null | 115 affected devices. | null | 1000123585 | 4 | 0 | No Action Indicated (NAI) | 2016-08-09 | 0 | 0 | null | false | 0 | device_malfunction | electrical shock hazard |
Z-0952-2019 | device | Arrow International Inc | AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a l... | Terminated | null | 2018-10-02 | 2019-03-06 | null | 26 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | cracked fill port connector |
D-0483-2017 | drug | Cherry Hill Sales Co. | MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28 | CGMP Deviations | Terminated | null | 2017-01-27 | 2017-03-01 | Michigan, Illinois, New York, Florida, Pennsylvania . | 3,600 cartons | null | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | manufacturing deviations |
Z-1321-2015 | device | Siemens Healthcare Diagnostics, Inc. | ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry systems are automated, clinical chemistry anal... | Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value miscalculation. | Terminated | null | 2015-01-19 | 2015-04-01 | null | 657 | null | 2432235 | 9 | 1 | No Action Indicated (NAI) | 2024-05-24 | 1 | 1 | 2012-05-29 | false | -1 | software | calibrator value error |
Z-0665-2013 | device | Siemens Healthcare Diagnostics, Inc. | Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum. | Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31. | Terminated | null | 2012-12-06 | 2013-01-16 | null | 1,998 cartons | null | 1219913 | 8 | 1 | Voluntary Action Indicated (VAI) | 2022-03-08 | 1 | 1 | 2012-05-10 | false | -1 | mislabeling | incorrect expiration date |
Z-0151-2023 | device | Boston Scientific Corporation | EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. | Ongoing | null | 2022-09-30 | 2022-11-09 | null | 7 devices | null | 2183460 | 6 | 0 | No Action Indicated (NAI) | 2016-02-24 | 0 | 0 | null | false | 0 | software | incorrect date display |
D-0632-2020 | drug | Granules India Limited | RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Ongoing | null | 2019-12-13 | 2020-01-08 | OR, NY, NJ | 23,090,000 tablets | 62207-773 | 3006583291 | 3 | 0 | No Action Indicated (NAI) | 2023-06-30 | 0 | 0 | null | false | -1 | cGMP | NDMA impurity in API |
D-0255-2021 | drug | Liq-E S.A. De C.V. | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477; NDC: XXXXX-378-04, UPC # 7 501799 118837 | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Terminated | null | 2020-07-20 | 2021-02-24 | Distributed Nationwide in the United States and Mexico. | 6,597 gallons | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | methanol presence |
D-0270-2024 | drug | SUN PHARMACEUTICAL INDUSTRIES INC | Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81. | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | Completed | null | 2024-01-18 | 2024-01-31 | Nationwide in the USA | 15,768 bottles | 47335-539 | 3028772083 | 1 | 0 | No Action Indicated (NAI) | 2024-02-15 | 0 | 0 | null | false | -1 | cGMP | equipment sanitation |
Z-0752-2024 | device | Randox Laboratories Ltd. | Calibration Serum Level 3 CAL2351 | CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%. | Ongoing | null | 2023-11-20 | 2024-01-24 | null | 269 kits | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | calibration bias shift |
Z-2137-2013 | device | Boston Scientific Corporation | Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.00mm x 15mm Small Peripheral Cutting Ball... | Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experienc... | Terminated | null | 2013-07-31 | 2013-09-11 | null | 1,331 | null | 2183460 | 6 | 0 | No Action Indicated (NAI) | 2016-02-24 | 0 | 0 | null | false | -1 | device_malfunction | protector cap removal |
Z-2231-2025 | device | 3M Company | 3M Ranger Irrigation Fluid Warming Set, REF 24750 | Notice was issued to clarify flow rates related to the inlet fluid temperature. | Ongoing | null | 2025-04-22 | 2025-08-06 | null | 186,880 units | null | 2110898 | 8 | 0 | No Action Indicated (NAI) | 2025-02-07 | 0 | 0 | null | false | 0 | software | flow rate calibration |
D-0107-2022 | drug | Vita Pharmacy, LLC dba Talon Compounding Pharmacy | BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 | Lack of assurance of sterility | Terminated | null | 2021-10-12 | 2021-11-17 | United States including Washington, D.C. and Puerto Rico | 1 vial | null | 3009192575 | 4 | 3 | Voluntary Action Indicated (VAI) | 2021-10-06 | 1 | 1 | 2017-10-03 | false | 0 | sterility | sterility assurance |
Z-0554-2020 | device | Boston Scientific Corporation | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670 | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | Terminated | null | 2019-10-21 | 2019-12-04 | null | 651 units | null | 3010178326 | 1 | 0 | Voluntary Action Indicated (VAI) | 2014-03-20 | 0 | 0 | null | false | 0 | mislabeling | incorrect shelf life |
D-0488-2022 | drug | Ultra Seal Corporation | PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507 | cGMP deviations | Terminated | null | 2022-01-24 | 2022-02-09 | Nationwide within the United States | 1,188,280 packets | null | 3014482156 | 1 | 0 | No Action Indicated (NAI) | 2020-01-22 | 0 | 0 | null | false | 0 | cGMP | manufacturing deviations |
D-0618-2020 | drug | Glenmark Pharmaceuticals Inc., USA | Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430 | Defective delivery system; product is not foaming or is coming out as liquid. | Terminated | null | 2019-11-15 | 2019-12-18 | Nationwide | a) 34521 bottles; b) 16930 bottles | 68462-608 | 3005658103 | 3 | 0 | No Action Indicated (NAI) | 2016-12-05 | 3 | 3 | 2010-03-16 | false | 0 | device_malfunction | defective delivery system |
D-626-2013 | drug | Baxter Healthcare Corp. | Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015 | Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. | Terminated | null | 2013-05-21 | 2013-07-10 | Nationwide & Puerto Rico | N/A | 0338-0424 | null | null | null | null | null | 0 | 0 | null | false | null | sterility | administration port leakage |
Z-0682-2023 | device | DeRoyal Industries Inc | DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03 | XXX | Ongoing | null | 2022-11-03 | 2022-12-21 | null | 56 kits | null | 3006369524 | 4 | 0 | Voluntary Action Indicated (VAI) | 2019-10-01 | 0 | 0 | null | false | 0 | other | insufficient information |
D-0675-2018 | drug | Partell Specialty Pharmacy | Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Terminated | null | 2018-03-22 | 2018-04-25 | NV only | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | unapproved sterilization method | |
D-1388-2012 | drug | Abbott Laboratories | Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05 | CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection. | Terminated | null | 2012-05-14 | 2012-06-27 | Nationwide | 121,000 vials | 0074-1658 | 1815692 | 31 | 1 | No Action Indicated (NAI) | 2025-04-04 | 1 | 0 | 2022-05-16 | false | -1 | cGMP | incorrect stopper application |
Z-2114-2017 | device | Sorin Group Italia SRL - CRF | INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias ... | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. | Terminated | null | 2017-04-11 | 2017-05-24 | null | 37 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | undetectable battery depletion |
Z-1273-2024 | device | FUJIFILM Healthcare Americas Corporation | Synapse PACS - Version 7.3.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | Ongoing | null | 2024-01-10 | 2024-03-13 | null | 64 Units (44 US, 20 OUS) | null | 1528028 | 4 | 0 | Voluntary Action Indicated (VAI) | 2017-02-06 | 0 | 0 | null | false | 0 | software | DICOM measurement error |
D-1801-2019 | drug | Infusion Options, Inc. | PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Terminated | null | 2019-06-12 | 2019-08-21 | NY only | N/A | null | 3008231170 | 2 | 2 | Official Action Indicated (OAI) | 2017-06-01 | 2 | 2 | 2021-08-26 | true | 0 | sterility | lack of sterility assurance |
Z-1511-2020 | device | Boston Scientific Corporation | Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generat... | Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration. | Terminated | null | 2020-02-12 | 2020-03-25 | null | 4 devices | null | 3032507796 | 2 | 0 | No Action Indicated (NAI) | 2016-12-14 | 0 | 0 | null | false | 0 | software | unapproved download |
Z-3078-2024 | device | Sol-Millennium Medical Inc. | Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model... | Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. | Ongoing | null | 2024-05-09 | 2024-09-18 | null | null | 3014312726 | 2 | 0 | Voluntary Action Indicated (VAI) | 2025-05-08 | 1 | 1 | 2024-03-18 | false | -1 | device_malfunction | uncleared design change | |
D-065-2013 | drug | GlaxoSmithKline, LLC. | Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709. | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. | Terminated | null | 2012-10-24 | 2012-12-05 | Nationwide and Puerto Rico. | 18,676 Aerosol Units | 0173-0715 | 3004055938 | 4 | 0 | No Action Indicated (NAI) | 2023-06-20 | 0 | 0 | null | false | -1 | stability | particle size distribution |
D-0272-2025 | drug | Central Admixture Pharmacy Services, Inc. | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1. | Presence of Particulate Matter | Ongoing | null | 2025-02-20 | 2025-03-19 | Product was distributed nationwide within the United States | 1546 bags | null | 3014307835 | 1 | 0 | Voluntary Action Indicated (VAI) | 2022-02-25 | 1 | 1 | 2024-03-25 | false | 0 | foreign_material | particulate matter |
Z-1161-2023 | device | MEDLINE INDUSTRIES, LP - Northfield | Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150; | The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. | Ongoing | null | 2022-12-27 | 2023-03-01 | null | 4,360 trays | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | improper sterilization placement |
Z-2125-2019 | device | Burlington Medical, LLC | Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing f... | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term e... | Terminated | null | 2019-06-07 | 2019-08-07 | null | 48 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | inadequate shielding |
Z-1919-2025 | device | Cardinal Health 200, LLC | Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. | Ongoing | null | 2025-05-13 | 2025-06-18 | null | 6517 cases total | null | 3010535719 | 2 | 0 | No Action Indicated (NAI) | 2016-08-23 | 0 | 0 | null | false | 0 | software | logic error handling |
Z-1942-2015 | device | Siemens Healthcare Diagnostics, Inc. | EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions. | System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification and quality control rules, and Sample reports. | Terminated | null | 2015-04-29 | 2015-07-08 | null | 1355 | null | 3009448641 | 1 | 0 | No Action Indicated (NAI) | 2017-11-29 | 0 | 0 | null | false | -1 | software | system limitations features |
Z-0982-2013 | device | Cardinal Health | Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 ... | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Terminated | null | 2012-12-18 | 2013-04-03 | null | Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184 | null | 3004347358 | 2 | 0 | No Action Indicated (NAI) | 2017-12-13 | 0 | 0 | null | false | -1 | packaging | compromised sterility barrier |
Z-2096-2014 | device | Terumo Cardiovascular Systems Corporation | Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications | Terminated | null | 2014-05-23 | 2014-07-30 | null | 7,190 units | null | 1828100 | 10 | 2 | No Action Indicated (NAI) | 2021-07-14 | 1 | 0 | 2011-03-29 | false | -1 | foreign_material | loose fiber particulate |
Z-0208-2016 | device | Siemens Medical Solutions USA, Inc. | e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has de... | Terminated | null | 2015-06-26 | 2015-11-11 | null | 32296 e.cam Gamma Camera systems | null | 2936884 | 4 | 0 | Voluntary Action Indicated (VAI) | 2016-04-15 | 0 | 0 | null | false | -1 | device_malfunction | brake failure mode |
D-783-2013 | drug | Lowlite Investments, Inc. D/B/A Olympia Pharmacy | Stanozolol (50 mg/ml and 100 mg/ml) 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 | 3 | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | QC process deficiency |
D-1593-2015 | drug | The Compounding Pharmacy of America | Morphine 30 mg/ml + Baclofen 10 mcg/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 volume | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | GMP violations |
Z-1012-2020 | device | Cardinal Health | AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC | 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 | 2000043510 | 1 | 0 | No Action Indicated (NAI) | 2021-08-24 | 0 | 0 | null | false | -1 | contamination | bioburden and particulates |
Z-0234-2026 | device | Medline Industries, LP | Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes | Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride. | Ongoing | null | 2025-09-11 | 2025-10-29 | null | 8,267,150 syringes | null | 3015274459 | 1 | 0 | No Action Indicated (NAI) | 2026-01-05 | 0 | 0 | null | false | -1 | potency | subpotent saline |
Z-2959-2020 | device | Terumo Cardiovascular Systems Corporation | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures. | Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms. | Terminated | null | 2020-08-25 | 2020-09-23 | null | 100 | null | 3000204839 | 6 | 0 | No Action Indicated (NAI) | 2024-02-16 | 0 | 0 | null | false | -1 | device_malfunction | faulty connector assembly |
Z-3371-2018 | device | B. Braun Medical, Inc. | CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous admin... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. | Terminated | null | 2018-07-20 | 2018-10-10 | null | 1032 | null | 3014301563 | 1 | 0 | Voluntary Action Indicated (VAI) | 2018-12-27 | 0 | 0 | null | false | -1 | device_malfunction | connector closure failure |
D-0363-2020 | drug | Altaire Pharmaceuticals, Inc. | Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Item #801486, NDC 0363-0191-50 | Lack of Assurance of Sterility | Completed | null | 2019-07-02 | 2019-11-27 | U.S.A. Nationwide | 45672 units | null | 1000119582 | 13 | 2 | No Action Indicated (NAI) | 2024-10-21 | 2 | 2 | 2020-03-12 | false | -1 | sterility | lack of assurance |
Z-0502-2017 | device | ICU Medical, Inc. | CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 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 ... | 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 | 100 units | null | 3013319212 | 8 | 2 | No Action Indicated (NAI) | 2024-09-09 | 2 | 2 | 2013-05-09 | false | -1 | device_malfunction | potential leak |
Z-1852-2013 | device | Hospira Inc. | List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Admi... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. | Terminated | null | 2013-04-01 | 2013-08-14 | null | 1,976 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | piercing pin defect |
Z-0523-2026 | device | Medline Industries, LP | MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B. | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the re... | Ongoing | null | 2025-09-30 | 2025-11-26 | null | 424 kits | null | 2125337 | 4 | 0 | Voluntary Action Indicated (VAI) | 2024-04-11 | 0 | 0 | null | false | 0 | device_malfunction | unintended activation |
Z-1103-2021 | device | DePuy Orthopaedics, Inc. | Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. | The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots. | Terminated | null | 2021-01-08 | 2021-02-17 | null | 60 sleeves | null | 1818910 | 8 | 1 | No Action Indicated (NAI) | 2024-03-28 | 2 | 2 | 2011-12-08 | false | -1 | cGMP | out of specification |
Z-0164-2024 | device | Medtronic Sofamor Danek USA Inc | Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch. | Ongoing | null | 2023-09-26 | 2023-11-01 | null | 282 units | null | 3007719715 | 1 | 0 | No Action Indicated (NAI) | 2011-02-23 | 0 | 0 | null | false | 0 | packaging | defective outer pouch |
Z-0112-2025 | device | Boston Scientific Corporation | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound ... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined t... | Ongoing | null | 2024-09-05 | 2024-10-23 | null | 1 unit | null | 1000120754 | 3 | 0 | Voluntary Action Indicated (VAI) | 2014-10-09 | 0 | 0 | null | false | 0 | software | grid overlay display |
Z-0690-2023 | device | DeRoyal Industries Inc | DeRoyal CNRV SPINAL PACK, REF 89-10532.03 | XXX | Ongoing | null | 2022-11-03 | 2022-12-21 | null | 69 kits | null | 3003040625 | 2 | 0 | No Action Indicated (NAI) | 2017-07-25 | 0 | 0 | null | false | 0 | other | unspecified reason |
Z-0935-2014 | device | Zest Anchors LLC | LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxi... | Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR¿ Implant Attachment Systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 N-cm. It was recently noted by Zest that in order to provide an optimal performance by increasing the f... | Terminated | null | 2014-01-16 | 2014-02-12 | null | 3,130 | null | 2023950 | 4 | 0 | Voluntary Action Indicated (VAI) | 2015-12-11 | 0 | 0 | null | false | -1 | mislabeling | incorrect torque specification |
Z-2338-2017 | device | Arrow International Inc | Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. | The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. | Terminated | null | 2017-05-09 | 2017-06-21 | null | 27,485 units distributed in U.S., 4,371 units distributed internationally | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | PICC catheter defect |
D-1686-2019 | drug | RXQ Compounding LLC | MORPHINE 1MG/ML IN NACL 0.9% 55ML SYR (C-II), 55 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0138-89 | Lack of Assurance of Sterility | Terminated | null | 2019-06-19 | 2019-08-14 | Nationwide USA | N/A | null | 3011509553 | 2 | 2 | Official Action Indicated (OAI) | 2017-08-08 | 1 | 1 | 2016-05-19 | true | 0 | sterility | lack of assurance |
D-1590-2012 | drug | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | OXYTOCIN 10UNITS/ML INJECTABLE 25 ML; OXYTOCIN**(25X1ML) 10U/ML INJECTABLE 25 MLS (2 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Terminated | null | 2012-05-21 | 2012-08-22 | Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies | 2 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | microorganism contamination |
D-0098-2018 | drug | Mayne Pharma Inc | Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01 | Failed Dissolution Specifications. | Terminated | null | 2017-11-09 | 2017-12-06 | Nationwide within USA | 11,364 bottles | null | null | null | null | null | null | 0 | 0 | null | false | null | potency | failed dissolution |
Z-0159-2025 | device | MEDLINE INDUSTRIES, LP - Northfield | Medline DENTAL PACK, REF DYNJ64086B; 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 | 165 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | breather pouch seal |
D-1172-2015 | drug | Lincare, Inc. | Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 6 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | 6 Bags | null | 3000717598 | 1 | 0 | No Action Indicated (NAI) | 2012-07-10 | 0 | 0 | null | false | 0 | sterility | unassured sterility |
Z-1850-2012 | device | Boston Scientific Corporation | Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an en... | Difficulty in extending snare loop from the catheter | Terminated | null | 2012-05-16 | 2012-06-27 | null | 2760 units | null | 3010178326 | 1 | 0 | Voluntary Action Indicated (VAI) | 2014-03-20 | 0 | 0 | null | false | -1 | device_malfunction | snare loop extension |
D-0575-2022 | drug | Dr. Reddy's Laboratories, Inc. | Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62 | Failed stability specifications | Terminated | null | 2022-01-19 | 2022-03-02 | USA Nationwide | 68061 vials | 43598-305 | 3011009040 | 1 | 0 | No Action Indicated (NAI) | 2025-08-21 | 0 | 0 | null | false | -1 | stability | failed specifications |
Z-0375-2022 | device | Cardinal Health | RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 | Potential for open packaging seals compromising the sterility of the surgical gowns | Ongoing | null | 2021-11-02 | 2021-12-22 | null | 364,481 units | null | 3004696355 | 2 | 0 | No Action Indicated (NAI) | 2022-03-17 | 0 | 0 | null | false | -1 | sterility | compromised seal |
D-0026-2023 | drug | Pharmacy Plus, Inc. dba Vital Care Compounder | ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Ongoing | null | 2022-10-07 | 2022-11-09 | AL, LA, MS, and TN | 1 droptainer | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of sterility assurance |
Z-0580-2017 | device | Atrium Medical Corporation | Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | Terminated | null | 2016-10-26 | 2016-11-23 | null | 4836 cases (10/cs) | null | 3011175548 | 10 | 4 | Voluntary Action Indicated (VAI) | 2024-11-26 | 1 | 1 | 2012-10-11 | false | -1 | mislabeling | incorrect product depiction |
Z-0725-2017 | device | Randox Laboratories, Limited | Magnesium on RX Imola analyser IVD | According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid wash recommended when setting up the magnesium assay. A correction was made to the IFU for the Magnesiu... | Terminated | null | 2016-04-14 | 2016-12-14 | null | 15 | null | 3004493545 | 3 | 0 | Voluntary Action Indicated (VAI) | 2016-04-28 | 0 | 0 | null | false | -1 | software | analyzer carryover |
D-0209-2020 | drug | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | Terminated | null | 2019-08-12 | 2019-11-13 | Nationwide in the USA | 5x10 ml and 5x30 ml glass vials | null | 3015235235 | 3 | 2 | Voluntary Action Indicated (VAI) | 2022-09-12 | 1 | 1 | 2020-09-10 | false | -1 | sterility | sterility assurance failure |
Z-0339-2018 | device | SPINEART SA | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by ... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. | Terminated | null | 2017-11-27 | 2018-01-24 | null | 9 units | null | 3007728266 | 2 | 1 | No Action Indicated (NAI) | 2016-12-08 | 0 | 0 | null | false | 0 | mislabeling | incorrect product illustration |
Z-2280-2019 | device | Codman & Shurtleff Inc | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). | Incorrect coil length on the label | Terminated | null | 2019-05-16 | 2019-08-21 | null | 28 units | null | null | null | null | null | null | 0 | 0 | null | false | null | mislabeling | incorrect dimensions |
Z-2321-2014 | device | Customed, Inc | MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2) LIGHT SHIELD (1) MAYO STAND COVER REINFOR... | Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. | Terminated | null | 2014-05-20 | 2014-09-10 | null | 35 lots; 11472 units (multiple units per lot) | null | null | null | null | null | null | 0 | 0 | null | false | null | packaging | compromised integrity |
D-1190-2015 | drug | Lincare, Inc. | Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | 2 Syringes | null | 1036092 | 1 | 0 | Voluntary Action Indicated (VAI) | 2010-01-13 | 0 | 0 | null | false | 0 | sterility | sterility assurance |
D-0324-2018 | drug | Flawless Beauty LLC | Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant t... | Terminated | null | 2018-01-19 | 2018-02-14 | Product was distributed U.S.A. nationwide. | N/A | null | null | null | null | null | null | 0 | 0 | null | false | null | other | unapproved drug marketing |
D-0669-2018 | drug | Partell Specialty Pharmacy | Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Terminated | null | 2018-03-22 | 2018-04-25 | NV only | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | non-approved sterilization | |
Z-0696-2014 | device | ICU Medical, Inc. | 13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration se... | 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 | 2025816 | 2 | 0 | No Action Indicated (NAI) | 2017-07-14 | 0 | 0 | null | false | -1 | device_malfunction | leaking connectors |
D-0672-2020 | drug | Assurance Infusion | BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated | null | 2019-12-20 | 2020-01-22 | Nationwide within the United States | 1 syringe | null | 3015617746 | 1 | 1 | Official Action Indicated (OAI) | 2019-12-03 | 1 | 1 | 2020-06-12 | true | 0 | sterility | inadequate assurance |
Z-0930-2013 | device | Siemens Medical Solutions USA, Inc. | ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image. | On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. | Terminated | null | 2013-01-18 | 2013-03-20 | null | 214 affected devices | null | 1034973 | 4 | 1 | No Action Indicated (NAI) | 2019-06-07 | 0 | 0 | null | false | -1 | device_malfunction | sharp edges hazard |
Z-2257-2018 | device | Quantimetrix Corporation | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reag... | The kits contained an incorrect lot of Dropper Plus Level 1 vials | Terminated | null | 2017-12-21 | 2018-06-27 | null | 20 kits | null | 2020715 | 2 | 0 | No Action Indicated (NAI) | 2014-05-19 | 0 | 0 | null | false | 0 | mislabeling | incorrect lot included |
Z-3285-2024 | device | Boston Scientific Corporation | WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | Ongoing | null | 2024-08-01 | 2024-10-02 | null | 305 units | null | 3005099803 | 7 | 0 | Voluntary Action Indicated (VAI) | 2024-11-26 | 0 | 0 | null | false | -1 | device_malfunction | catheter tip detachment |
Z-2383-2014 | device | Customed, Inc | PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12' UF (1) TABLE COVER REINFORCED 50" X 9... | Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. | Terminated | null | 2014-05-20 | 2014-09-10 | null | 2 lots; 258 units (multiple units per lot) | null | null | null | null | null | null | 0 | 0 | null | false | null | packaging | compromised integrity |
Z-1900-2015 | device | Covidien LLC | Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P | Catheters may not meet antimicrobial specification | Terminated | null | 2015-04-23 | 2015-07-08 | null | 72,363 US - 24,631 Internationally | null | 3011410703 | 3 | 0 | Voluntary Action Indicated (VAI) | 2016-03-11 | 0 | 0 | null | false | -1 | potency | antimicrobial efficacy |
D-0087-2024 | drug | PAR Sterile Products LLC | Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05 | Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples. | Terminated | null | 2021-11-09 | 2023-11-15 | Nationwide USA | 42023-179 | null | null | null | null | null | 0 | 0 | null | false | null | stability | crystallization formation | |
Z-1330-2024 | device | Covidien | Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 | Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if... | Ongoing | null | 2024-02-21 | 2024-03-27 | null | 755,800 | null | 2024500 | 1 | 0 | No Action Indicated (NAI) | 2011-04-04 | 0 | 0 | null | false | 0 | device_malfunction | missing sterilization step |
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