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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

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 14, 2020 BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential sta... May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit... Class II Becton Dickinson & Co.
Apr 14, 2020 BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorgan... May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit... Class II Becton Dickinson & Co.
Apr 14, 2020 BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorga... May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit... Class II Becton Dickinson & Co.
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 008863... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 0088633... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UD... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Mar 18, 2020 Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M00617527208... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M00617526... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M00667... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M00667030... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M006... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Feb 25, 2020 Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrate... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 25, 2020 Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 25, 2020 Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Tra... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 25, 2020 Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Tran... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 14, 2020 The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; ... Firm identified software issues which leads to the patient ID and patient information not being s... Class II ICU Medical, Inc.
Feb 12, 2020 Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR,... Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... Class II Boston Scientific Corporation
Feb 12, 2020 Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile.... Proximal end of the driver in the affected product may be oversized in varying degrees, potentia... Class II Nextremity Solutions
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 ... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular

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.