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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

Clear
DateProductReasonClassFirm
Feb 7, 2013 Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medi... Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. Class II Myco Medical Supplies Inc
Feb 4, 2013 EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessori... EsophyX2Plus device was not validated under actual or simulated use conditions prior to distribut... Class II Endogastric Solutions Inc
Jan 28, 2013 Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATES... Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a ... Class II Diagnostica Stago, Inc.
Jan 25, 2013 Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066... Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor),... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jan 25, 2013 Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operato... Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor),... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jan 23, 2013 Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product... Affected products have a labeled expiration date of one year too long. Class III Bion Enterprises Ltd
Jan 23, 2013 Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product... Affected products have a labeled expiration date of one year too long. Class III Bion Enterprises Ltd
Jan 23, 2013 Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Pro... Affected products have a labeled expiration date of one year too long. Class III Bion Enterprises Ltd
Jan 21, 2013 Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needl... The label on the device states that the item number is CLGY-2210 when the item number on the devi... Class II Churchill Medical Systems, Inc.
Jan 17, 2013 SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; Sybr... A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... Class II Ormco/Sybronendo
Jan 17, 2013 SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; ... A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... Class II Ormco/Sybronendo
Jan 17, 2013 KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Mod... Missing symbols and manufacturing information on the clear carton label. The expiration dating s... Class III Carestream Health, Inc.
Jan 14, 2013 Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate... Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labe... Class II Atricure Inc
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 7 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 11, 2013 Inspira AIR Balloon Dilation system. Size 16 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 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.

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.