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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

5,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,428 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 5,428 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc.... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 8, 2013 Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) label... Neonatal beds and incubator display boards may randomly overwrite stored information and radiant ... Class I GE Healthcare, LLC
Jan 4, 2013 The product is labeled in part "***Surgical Laser Technologies, Inc. Montgome... Firm became aware that some products within the specified lot may not have been sealed appropriat... Class II PhotoMedex, Inc.
Jan 2, 2013 The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for ... Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective lab... Class I Lumenis Limited
Dec 28, 2012 CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: ... Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... Class II Veridex, LLC
Dec 28, 2012 CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usag... Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... Class II Veridex, LLC
Dec 20, 2012 Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035P... A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". Class II Medisystems a NX Stage Company
Dec 20, 2012 Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB ... Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge ... Class II Medisystems a NX Stage Company
Dec 20, 2012 AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with... Two production orders of these IOLs that contain mislabeled IOLs. Class II Abbott Medical Optics Inc (AMO)
Dec 20, 2012 HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoP... The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has t... Class II Healthtronics, Inc.
Dec 17, 2012 Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F... Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" ne... Class II Vygon Corporation
Dec 13, 2012 Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "C... Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the sutu... Class II Riverpoint Medical, LLC
Dec 13, 2012 REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product ... The affected product was packaged with the incorrect introducer needle. The kit label indicates ... Class II Medical Components, Inc dba MedComp
Dec 11, 2012 BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:*... Cartridges are not sealing properly during PCR testing and may cause false results, indeterminate... Class II Becton Dickinson & Co.
Dec 10, 2012 BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in p... Enrichment media intended to enhance the cultivation of various microorganisms may fail to suppo... Class II Becton Dickinson & Co.
Dec 3, 2012 SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protect... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Nov 28, 2012 Pinnacle Cancellous Screw Packaging: Product is housed within a polyuretha... DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle¿ Cancellous Sc... Class II DePuy Orthopaedics, Inc.
Nov 21, 2012 Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mc... Boxes labeled as CIP5 may contain cartridges of AMP5. Class III Remel Inc
Nov 19, 2012 Patient Circuit used with the Life Pulse High Frequency Ventilator. The Pati... Customer complaints received indicate the heater wire insulation can melt, causing a short which ... Class I Bunnell, Inc.
Nov 16, 2012 DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DeP... Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labele... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 15, 2012 EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk... Class II EEG Info
Nov 14, 2012 Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Tr... RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining i... Class II Leica Microsystems, Inc.
Nov 13, 2012 The Vertex Max Drill Tube is a component within the Navigated Vertex Max Dril... Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation Syst... Class II Medtronic Navigation, Inc.
Nov 8, 2012 Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescr... The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in... Class II Medline Industries Inc
Nov 6, 2012 BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton,... An antibiotic susceptibility test kit may produce false intermediate or false resistant results w... Class II Becton Dickinson & Co.
Nov 5, 2012 Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, ... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, Inc.
Nov 5, 2012 Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMW... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, 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.