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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

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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

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 14, 2016 Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJ... A number of Agee WristJack¿ Fracture Reduction Systems have been manufactured with a molded beam ... Class II Hand Biomechanics Lab Inc
Aug 26, 2016 Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patie... The connector may disconnect from the tracheostomy tube during use. Class I Teleflex Medical
Aug 24, 2016 SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number ... Siemens received multiple customer complaints indicating an increase in false positive and indete... Class II Siemens Healthcare Diagnostics, Inc.
Aug 24, 2016 Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device... ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices. Class II ICU Medical, Inc.
Aug 24, 2016 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacter... Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the... Class I Baxter Corporation Englewood
Aug 24, 2016 SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number ... Siemens received multiple customer complaints indicating an increase in false positive and indete... Class II Siemens Healthcare Diagnostics, Inc.
Aug 23, 2016 Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, package... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, ... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 17, 2016 HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and... Foreign material found within the driveline connector of the HVAD Pump that could cause increased... Class I HeartWare, Inc
Aug 12, 2016 Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 12, 2016 Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 10, 2016 Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Adm... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Port... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 m... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sam... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Produc... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservo... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Sque... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Nee... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and N... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reser... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syri... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Tran... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: T... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, D... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Rese... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product U... Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class II LeMaitre Vascular, Inc.
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product ... Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class II LeMaitre Vascular, Inc.
Aug 3, 2016 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-... Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class II LeMaitre Vascular, Inc.
Jul 20, 2016 BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, ... Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specif... Class II Cardinal Health
Jul 15, 2016 Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOP... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jul 15, 2016 Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH E... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jul 1, 2016 DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot ... BD, formerly CareFusion, has identified a potential risk associated with a weld failure which cou... Class I Carefusion 2200 Inc
Jun 30, 2016 Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 22, 2016 Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog #... Risk associated with operating the device in skin temperature mode with temperature sensors attac... Class II Draeger Medical, Inc.
Jun 14, 2016 T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged i... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 5... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC
Jun 14, 2016 Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches p... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, 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.