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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

Infrastructure

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

680 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 680 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 680 FDA device recalls.

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DateProductReasonClassFirm
Feb 11, 2015 Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5m... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5m... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Jan 12, 2015 Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxx... Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occas... Class II Covidien LP (formerly Nellcor Puritan Bennett I...
Dec 10, 2014 Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT60803... A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation por... Class I Covidien
Dec 10, 2014 Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, ... A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation por... Class I Covidien
Oct 1, 2014 Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ... A software issue may lead to ventilator inoperative situations. Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Oct 1, 2014 Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien ... Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter... Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Sep 18, 2014 Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number:... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 MediChoice¿ Multifunction Electrode Part Number: MC171 OH Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number:... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation E... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pr... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Jul 17, 2014 Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other ... Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jul 17, 2014 Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other elect... Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jun 4, 2014 Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a compone... In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator con... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jun 3, 2014 Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator Syst... Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventila... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating,... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating,... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 28, 2014 HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guid... Class I Nitinol Devices and Components, Inc.
May 8, 2014 Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 3115... Straps may separate from the foam pad. Class II Covidien LLC
Apr 18, 2014 Recalled product is a component of the Newport Medical Instruments e360 Vent... Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilat... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
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.
Dec 16, 2013 Puritan Bennett 840 ventilator systems software part number 4-070212-85, revi... Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator syst... Class I Covidien
Dec 5, 2013 Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Produc... The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position. Class II Integra LifeSciences Corp.
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 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
Jul 19, 2013 Pipeline Embolization Device (PED) The Pipeline Embolization Device is ind... Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
May 6, 2013 Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST ... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code:... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONB... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Produ... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Produc... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP

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.