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Vehicle Safety

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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

5,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,428 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 5,428 FDA device recalls.

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DateProductReasonClassFirm
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.
Apr 10, 2014 Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixatio... Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result... Class II Synthes, Inc.
Apr 9, 2014 ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF:... Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a prod... Class II Ev3, Inc.
Apr 7, 2014 SBi RingFix Olive Wires Product Usage: These are temporary devices indica... Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-30... Class II Small Bone Innovations, Inc.
Apr 4, 2014 Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against h... Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present i... Class II BD Biosciences, Systems & Reagents
Apr 3, 2014 AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for p... Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increase... Class II Baxter Healthcare Corp.
Apr 2, 2014 ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculat... 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values durin... Class I Baxter Corporation Englewood
Mar 28, 2014 Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE... Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ C... Class II Terumo Cardiovascular Systems Corp
Mar 28, 2014 Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number... New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfi... Class II Integra LifeSciences Corporation
Mar 26, 2014 ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, P... May be labeled with incorrect result interpretation graphics on the ToxCup lid label. Class II Branan Medical Corporation
Mar 25, 2014 Reusable latex breathing bags with multiple part numbers and sold as part of ... Reusable latex breathing bags with various part numbers and sold as part of test lung and reusabl... Class II Draeger Medical, Inc.
Mar 24, 2014 AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5... There is a possibility the sterile packaging may fail before the expiration date specified on the... Class II Soma Access Systems LLC
Mar 19, 2014 DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment,... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatmen... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral st... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides com... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, 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.