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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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
Aug 7, 2014 PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 5, 2014 CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes a... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefil... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefill... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Jul 18, 2014 Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flu... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stri... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 0... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Mac... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device a... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and ... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valv... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 11, 2014 Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TK... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intr... Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which... Class II Medtronic Neuromodulation
Jul 11, 2014 Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 7, 2014 H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediat... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric ... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediat... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 3, 2014 Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessori... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessor... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 8... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ C... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Access... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Cert... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jun 23, 2014 Cordis EMPIRA RX PTCA Dilatation Catheter The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected... Class II Cordis Corporation
Jun 23, 2014 Cordis EMPIRA NC RX PTCA Dilatation Catheter The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected... Class II Cordis Corporation
Jun 12, 2014 Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREA... Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 we... Class II Zimmer Manufacturing B.V.
Jun 12, 2014 Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350... A small number of sealed foil pouches containing the electrodes were found to be difficult to ope... Class II Heartsine Technologies, Limited
Jun 11, 2014 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DAT... Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow ... Class I GE Healthcare, LLC
Jun 10, 2014 Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral C... A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an e... Class II Zimmer, Inc.
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 6, 2014 CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an en... A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... Class II Becton Dickinson & Co.
Jun 3, 2014 RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. R... The product can be difficult to remove from the Distal Stem both out of the package and after pr... Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manua... The product can be difficult to remove from the Distal Stem both out of the package and after pr... Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sl... The product can be difficult to remove from the Distal Stem both out of the package and after pro... Class II DePuy Orthopaedics, Inc.
May 23, 2014 Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
May 23, 2014 CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherect... CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because i... Class I Cardiovascular Systems, Inc.
May 23, 2014 Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, sut... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems 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.