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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

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

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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.

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DateProductReasonClassFirm
Feb 16, 2017 Cordis S.M.A.R.T. Flex Vascular Stent System Deployment Difficulty. Class II Cordis Corporation
Feb 10, 2017 StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI... Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit diff... Class II Abbott Vascular
Feb 3, 2017 HeartWare HVAD System Controller The HeartWare Ventricular Assist System (V... Product recall of all HVAD Controllers currently on the market and to exchange them for the next... Class I Heartware
Jan 10, 2017 LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Mo... Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal ... Class II Encore Medical, Lp
Dec 19, 2016 Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComX... Product complaints indicated that the part and lot numbers on the packaging differed from the phy... Class II Zimmer Biomet, Inc.
Dec 19, 2016 NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System... Dimensional non-conformity of the thread on the screw head. Class II In2Bones, SAS
Dec 19, 2016 NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois... Dimensional non-conformity of the thread on the screw head. Class II In2Bones, SAS
Dec 19, 2016 SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin ... Dimensional non-conformity of the thread on the screw head. Class II In2Bones, SAS
Dec 15, 2016 ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(lo... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32.... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM ... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.01... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenic... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.00... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.01... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.0... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.00... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 13, 2016 Chord-X Chordal Sizer is designed to assist in determining the proper length ... Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Lef... Class II On-X Life Technologies, Inc.
Dec 9, 2016 Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M... During internal testing conducted as part of next generation product development, it was discover... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Dec 6, 2016 Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Ste... Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mis... Class II Zimmer Biomet, Inc.
Nov 30, 2016 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating... ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a... Class II ICU Medical, Inc.
Nov 30, 2016 AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A sin... A complaint of the PRO2 jaw breaking prior to surgery being performed. Class II AtriCure, Inc.
Nov 22, 2016 Ceres-C Standalone Cervical Interbody The product is a stand-alone anterio... Absent tantalum market pin. Class II Amendia, Inc
Nov 7, 2016 MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses ... Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Integ... Class II Bayer Healthcare
Nov 7, 2016 Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6... Firm received reports about "acquisition errors" and the deterioration of material covering the a... Class II Siemens Medical Solutions USA, Inc.
Oct 21, 2016 is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t... Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. Class III Euro Diagnostica AB
Oct 21, 2016 is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t... Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. Class III Euro Diagnostica AB
Oct 21, 2016 is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for t... Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. Class III Euro Diagnostica AB
Oct 12, 2016 GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1... Potential presence of particulate matter on the blood side of the dialyzer Class II Baxter Healthcare Corp.
Oct 10, 2016 Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Oct 10, 2016 Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quad... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Oct 10, 2016 Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, C... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Sep 27, 2016 SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 The... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 460... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The Tr... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush D... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringe... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac D... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 The T... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4259... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposab... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 460... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Transpac¿ IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing, Reservoir... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Cath Lab Kit w/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac¿ I... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, 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.