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

3,264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,264 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 3,264 FDA device recalls.

Clear
DateProductReasonClassFirm
Oct 7, 2019 NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545... There is a remote potential for the sterile packaging of the transseptal guiding sheath to be com... Class II Baylis Medical Company Inc.
Oct 7, 2019 TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-5... There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath t... Class II Baylis Medical Company Inc.
Oct 3, 2019 Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave... One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier... Class II Datascope Corp.
Oct 1, 2019 Aesculap Sterile disposable fleece drape, Product code: GA414, individually p... Packaging seal integrity not validated resulting in a lack of sterility assurance. Class II Aesculap Implant Systems LLC
Sep 12, 2019 Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is t... labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the in... Class II Merit Medical Systems, Inc.
Aug 30, 2019 SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G... Problem with packaging sealing process which affects sterility. Class II Pajunk GmbH
Aug 28, 2019 NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); R... The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implan... Class II Nobel Biocare Usa Llc
Aug 22, 2019 iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient... Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. Class II Conformis, Inc.
Aug 22, 2019 iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient... Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. Class II Conformis, Inc.
Aug 21, 2019 Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthop... Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the... Class II Zimmer GmbH
Aug 14, 2019 Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40... The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended ... Class II Bard Peripheral Vascular Inc
Aug 9, 2019 Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigati... Samples in the identified lot were found to have incomplete or open packaging seals. Class II Medline Industries Inc
Jul 24, 2019 The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a late... incorrect device size being listed on the impacted device packaging Class II LeMaitre Vascular, Inc.
Jul 1, 2019 STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used ... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for perform... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driv... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used f... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used f... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regio... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for lac... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceratio... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:Th... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performi... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Drivelin... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit i... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jun 19, 2019 Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
May 28, 2019 K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Expre... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 28, 2019 DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: The... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 28, 2019 DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: Th... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 23, 2019 Various products which were contract sterilized. The contract sterilizer did not have adequate packaging data to support the 2-year shelf life. Class II Anewmed Corporation
May 2, 2019 Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT The products may have been manufactured without the bottom seal on the outer packaging, compromis... Class II Cook Inc.
Apr 10, 2019 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC... The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... Class II Stryker Neurovascular
Apr 10, 2019 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC... The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... Class II Stryker Neurovascular
Apr 3, 2019 Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article ... Dental adaptor does not conform to specifications. The dental coupling of the adapter can become ... Class II Thommen Medical AG
Apr 1, 2019 Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical interverteb... Incorrect part description contained on an additional label placed on the packaging: A 14mm lengt... Class II Zimmer Biomet, Inc.
Mar 19, 2019 Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... During manufacture, packaging materials for a small portion of the lot may not have been properly... Class II Stryker Instruments Div. of Stryker Corporation
Mar 14, 2019 Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twi... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can ... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instrument... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Kit - Product Usage: The kit itself does not have a specifi... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They ca... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twi... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: Th... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc

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.