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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 5,543 FDA device recalls.

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DateProductReasonClassFirm
May 20, 2014 NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS RE... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDP... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1)... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOW... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10)... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Customed Femoral Pack , convenience pack include multiple components: Syringe... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAF... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REI... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICA... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTIO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 16, 2014 GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoa... Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in ... Class II Nidek Inc
May 15, 2014 Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 ... Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simpl... Class II Focus Diagnostics Inc
May 15, 2014 Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming... All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the pack... Class II Synthes, Inc.
May 15, 2014 Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical... The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014)... Class II Bacterin International, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicate... Unit was mislabeled with a factory label showing 32 KW output power. Class III AGFA Healthcare Corp.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 6, 2014 Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim ... Marketing without marketing clearance or approval. Class II Advanced Photonic Systems, LLC
May 6, 2014 Photonica Light Modulator. These include all products labeled as UltraSlim, L... Marketing without marketing clearance or approval. Class II Advanced Photonic Systems, LLC
May 6, 2014 Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim... Marketing without marketing clearance or approval. Class II Advanced Photonic Systems, LLC
May 5, 2014 ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: T... "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marke... Class I DIABETIC SUPPLY OF SUNCOAST, INC.
Apr 23, 2014 Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Sutu... CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absor... Class II C P Medical Inc.
Apr 22, 2014 UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrate... Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron ... Class II Beckman Coulter Inc.
Apr 18, 2014 Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a t... Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry d... Class II Leica Microsystems, Inc.
Apr 17, 2014 Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed usi... Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an ele... Class II Nanosphere, Inc.
Apr 17, 2014 APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233... Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collectio... Class III Gen-Probe Inc
Apr 16, 2014 RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF... Possible breach in sterile barrier for inner and outer bags of the product. Class II Baxter Corporation Englewood
Apr 14, 2014 Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Ti... Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm... Class II Merit Medical Systems, Inc.
Apr 14, 2014 Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard S... Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the c... Class II Merit Medical Systems, Inc.
Apr 14, 2014 ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Mete... Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneous... Class II Roche Diagnostics Operations, Inc.
Apr 10, 2014 Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The c... One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in... Class I Smiths Medical ASD, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.