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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

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
Apr 9, 2018 smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 7... A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error.... Class II Smith & Nephew, Inc.
Apr 9, 2018 VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux S... Invalid calibration with low calibrator S1 while using the product. Class II BioMerieux SA
Apr 6, 2018 Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Pa... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Num... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on labe... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Pa... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on ... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Pa... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: ... The retail shelf cartons may be labeled with an incorrect lot number. Class II MHC Medical Products LLC
Apr 6, 2018 EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: IN... The retail shelf cartons may be labeled with an incorrect lot number. Class II MHC Medical Products LLC
Apr 6, 2018 T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Le... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx On... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Par... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 6, 2018 Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx ... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ... Class II Orthofix, Inc
Apr 4, 2018 Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage:... Tip of the curing light was too hot causing a heat sensation in the patients. Class II Handpiece Headquarters
Apr 2, 2018 Bivona¿ Tracheostomy Tube Tracheostomy Tubes Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as s... Class II Smiths Medical ASD Inc.
Mar 23, 2018 The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to ... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Num... Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fib... Class II Medtronic Navigation, Inc.
Mar 21, 2018 Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Pro... Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iod... Class II Bard Medical Division
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 20, 2018 BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ ... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 20, 2018 BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 3... Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class II Becton Dickinson & Company
Mar 19, 2018 Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVI... Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... Class II Teleflex Medical Europe Ltd
Mar 16, 2018 Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 3661... The product label has missing information, such as the lot number and expiration date, as well as... Class II Nobel Biocare Usa Llc
Mar 15, 2018 URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type... Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling o... Class II Biocare Medical, LLC
Mar 14, 2018 ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platfor... The cap on the vial might be labeled with the incorrect part number but the main vial label is co... Class II Implant Direct Sybron Manufacturing, LLC
Mar 14, 2018 Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Ac... The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus ident... Class II Accelerate Diagnostics Inc
Mar 13, 2018 Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 05071... Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in t... Class II LivaNova USA
Mar 13, 2018 Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 05071... Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in t... Class II LivaNova USA
Mar 13, 2018 Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F ... The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, r... Class II Medtronic Vascular
Mar 12, 2018 Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TM... This device was mislabeled and is not the correct component for this patient. Class II TMJ Solutions Inc
Mar 12, 2018 Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of ... The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labe... Class II Stryker GmbH
Mar 9, 2018 Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD.... The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the... Class II The Binding Site Group, Ltd.
Mar 8, 2018 SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) i... The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. Class II Southern Implants, (Pty.) Ltd.
Mar 7, 2018 Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resteri... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, 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.