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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
Aug 26, 2013 Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, ... Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi... Class II Edwards Lifesciences, LLC
Aug 26, 2013 Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL... Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. Class II Biomet 3i, LLC
Aug 21, 2013 SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cut... No antibacterial bandages were packed in boxes labeled as antibacterial. Class II ASO, LLC
Aug 19, 2013 TEGRIS system Four labels of the Tegris System include: Emergency butt... MAQUET has identified a potential issue that might occur because of the lack of an emergency stop... Class II Maquet Cardiovascular Us Sales, Llc
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Pr... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Pr... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Prod... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Produc... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006.... Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter becau... Class II Access Scientific Inc
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill P... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Produc... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 12, 2013 Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed i... A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... Class II MicroAire Surgical Instruments, LLC
Aug 12, 2013 Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introd... Due to a labeling error related to the conversion of the inner diameter of the catheter from inch... Class II Cordis Corporation
Aug 12, 2013 DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoy... One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable p... Class II DeRoyal Industries Inc
Aug 12, 2013 Steinmann Pin, packed in a clear tube with end caps, tubes packed in a steril... A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... Class II MicroAire Surgical Instruments, LLC
Aug 12, 2013 ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN... Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120... Class II Siemens Healthcare Diagnostics
Aug 9, 2013 Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTI... OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could pe... Class II OPTI Medical Systems, Inc
Aug 8, 2013 Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, S... The manufacturing and expiration dates are not printed on the blister pack label. Class II Teleflex Medical
Aug 7, 2013 Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syrin... Manufacturer made a change in the production process that resulted in a change in final gel weigh... Class I Enhancement Medical, LLC
Aug 2, 2013 Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50... AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viabil... Class II Getinge USA Inc
Jul 31, 2013 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixatio... Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issu... Class II Synthes USA HQ, Inc.
Jul 31, 2013 Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The ... Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock state... Class II Arrow International Inc
Jul 30, 2013 ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLAT... Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, ... Class II Zimmer, Inc.
Jul 30, 2013 Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for frac... A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. Class II Synthes (USA) Products LLC
Jul 30, 2013 Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fi... Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect label... Class II Synthes USA HQ, Inc.
Jul 30, 2013 Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog n... One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the produ... Class II Synergetics Inc
Jul 29, 2013 SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSI... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENS... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 26, 2013 Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1... The operators manual does not fully describe the sequence of expected events that will occur when... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2013 Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System ... The operators manual does not fully describe the sequence of expected events that will occur when... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2013 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan... TCVS is taking action to update the Operators Manual with the specific instructions to respond to... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2013 Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovas... Medical device used in cardiovascular procedures is defective. Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2013 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan... TCVS is taking action to update the Operators Manual with the specific instructions to respond to... Class II Terumo Cardiovascular Systems Corporation
Jul 25, 2013 Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 a... Review of on-system electronic product labeling and Instructions for comply with applicable Use i... Class II Medtronic Navigation, Inc.
Jul 24, 2013 GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St... On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated... Class II Gyrus Medical, Inc
Jul 24, 2013 Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 083104... Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they... Class II Nestle HealthCare Nutrition
Jul 23, 2013 DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott L... Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an un... Class II Microgenics Corp
Jul 18, 2013 Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Late... Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sa... Class II Aspen Surgical Products, Inc.
Jul 17, 2013 Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalo... Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due ... Class II Arrow International Inc
Jul 17, 2013 Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 90... Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System... Class II Hospira Inc.
Jul 17, 2013 Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Cat... The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW... Class II Arrow International Inc
Jul 16, 2013 Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (... Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. ... Class III Zoll Circulation, Inc.
Jul 12, 2013 Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular r... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation

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.