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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
Mar 31, 2016 American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) P... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.... When using the recalled product in split shift mode, the non-sub-millimeter positioning has been ... Class II Med Tec Inc
Mar 31, 2016 American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 CF InPlex ASR Card; Catalog Number: 95-0501. Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive ... Class II Hologic, Inc
Mar 31, 2016 American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Produc... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (... A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLin... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Mar 31, 2016 American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgi... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Ne... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Pro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog... Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ... Class III Biocare Medical, LLC
Mar 31, 2016 American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Produ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company

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.