Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

Clear
DateProductReasonClassFirm
Aug 19, 2014 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Contr... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 8, 2014 CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is desig... CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ven... Class I CareFusion 203, Inc.
Jul 17, 2014 CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-... This remedial action is the result of six product complaints associated with separation of the sn... Class I Cook 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 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 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 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 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 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 2, 2014 The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... Class I Hospira Inc.
Jul 2, 2014 The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... Class I Hospira Inc.
Jul 2, 2014 The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... Class I Hospira Inc.
Jul 2, 2014 The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... Class I Hospira Inc.
Jul 2, 2014 The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... Class I Hospira Inc.
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 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 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, 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 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
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 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 Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are inten... The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about vi... Class I Childrens Medical Ventures
May 27, 2014 Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions... The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub du... Class I Vascular Solutions, Inc.
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 20, 2014 Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) C... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTIO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9"... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAN... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CU... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICA... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24"... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REI... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APP... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, 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.