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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 25, 2014 BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier ... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 13, 2014 Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; S... Internal testing had identified a potential breach to the sterile barrier that may impact the ste... Class II Volcano Corporation
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 6, 2014 Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Me... The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline F... Class II Arrow International 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.
Aug 1, 2014 CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STO... A pinhole leak identified in the packaging of the recalled product potentially could compromise t... Class II Civco Medical Instruments Inc
Jul 25, 2014 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe ... Unit packages may exhibit open seals which impacts package integrity and potentially product ster... Class II Centurion Medical Products Corporation
Jun 20, 2014 LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. L... Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a s... Class II Laser Peripherals LLC
Jun 20, 2014 Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Steril... Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially... Class II Stryker Endoscopy
Jun 12, 2014 McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single ... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Us... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical A... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Ind... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical A... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Indu... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Actio... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 11, 2014 Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. T... Lack of Sterility Assurance Class II PIONEER SURGICAL TECHNOLOGY, INC.
Jun 3, 2014 eye-pak 7407 Tray Support Cover REF 8065740745 The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot... Class II Alcon Research, Ltd.
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Co... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 722038... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, f... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 722... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fast... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
May 20, 2014 ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15"... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REI... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOW... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSO... 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.