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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

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Clear
DateProductReasonClassFirm
Jun 25, 2019 K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioP... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Access... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 24, 2019 IQon Spectral CT Model # 728332, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Vereos PET/CT Model # 882446, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 Ingenuity Core Model # 728321, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 RX Imola, Model Nos. RX4900 There was a report of a malfunction with the sensor which resulted in an increase of temperature ... Class II Randox Laboratories, Limited
Jun 24, 2019 TAPSYSTEM Model 2A, REF 8002A There is a potential for an assembly error resulting in the battery wire being connected to the O... Class III Cardiocommand Inc.
Jun 24, 2019 iCT SP Model # 728311, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 RX Daytona, Model Nos. RX4040 and RX4041 There was a report of a malfunction with the sensor which resulted in an increase of temperature ... Class II Randox Laboratories, Limited
Jun 24, 2019 Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Mag... The QA software solution to perform the MR to MV alignment check, does not display the stored MR ... Class II Elekta, Inc.
Jun 24, 2019 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile E... The firm has become aware that they have distributed product that was expired. Class II OriGen Biomedical, Inc.
Jun 24, 2019 Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1... The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri... Class I Fenwal Inc
Jun 24, 2019 YNHH SCOPE KIT Kit Code: MNS10475 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manuf... Class II Centurion Medical Products Corporation
Jun 24, 2019 Ingenuity CT, Model # 728326, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 iCT, Model # 728306, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 EPISTAXIS TRAY Kit Code: MNS10165 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manuf... Class II Centurion Medical Products Corporation
Jun 24, 2019 Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Prod... The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri... Class I Fenwal Inc
Jun 24, 2019 Brilliance 64 Model # 728231, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 24, 2019 NOSEBLEED TRAY Kit Code: MNS3885 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manuf... Class II Centurion Medical Products Corporation
Jun 24, 2019 Ingenuity Core128 Model # 728323, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... Class II Philips Medical Systems (Cleveland) Inc
Jun 21, 2019 A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped... Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Se... Class II Alto Development Corp
Jun 20, 2019 ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: ... Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: ... Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 Norm-O-Temp model 111W The manual does not provide instruction stating that exceeding 40 Celsius for extended periods ca... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Jun 20, 2019 Cios Alpha VA20/ VA30 mobile X-Ray systems DAP chamber may be missing an insulating foil Class II Siemens Medical Solutions USA, Inc
Jun 20, 2019 Norm-O-Temp model 111Z The manual does not provide instruction stating that exceeding 40 Celsius for extended periods ca... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Jun 20, 2019 Cios care fusion system DAP chamber may be missing an insulating foil Class II Siemens Medical Solutions USA, Inc
Jun 20, 2019 ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: ... Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 19, 2019 Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrod... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, 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.