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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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Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
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 5, 2018 Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 T... A failure of the tube arm suspension is possible while the tube arm height is being adjusted. Du... Class II Visaris DOO
Apr 5, 2018 Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Crani... The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on ... Class II Zimmer Biomet, Inc.
Apr 5, 2018 Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 1... Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlu... Class I Abbott
Apr 5, 2018 Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 ... A failure of the tube arm suspension is possible while the tube arm height is being adjusted. Du... Class II Visaris DOO
Apr 5, 2018 Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 ... A failure of the tube arm suspension is possible while the tube arm height is being adjusted. Du... Class II Visaris DOO
Apr 4, 2018 IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative M... The DC power to the IFOSS collision detector control panel at your facility is being adversely af... Class II Deerfield Imaging, Inc.
Apr 4, 2018 CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 ... There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to ... Class II Maquet Cardiopulmonary Ag

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.