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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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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 19, 2019 Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 Potential for iGUIDE to incorrectly monitor the 3D position. Class II Elekta, Inc.
Jun 19, 2019 Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, Inc.
Jun 19, 2019 Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, Inc.
Jun 19, 2019 Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009 It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the ... Class II Seca
Jun 19, 2019 Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electr... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, Inc.
Jun 19, 2019 ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity... Potential for failed stability antimicrobial effectiveness testing. Class II Pharmaceutical Innovations, Inc.
Jun 18, 2019 Skull Anchor Bolts Supplemental information provided with devices may indicate that the subdural electrodes, depth e... Class II Ad-Tech Medical Instrument Corporation
Jun 18, 2019 LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. ... The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal. Class II CooperSurgical, Inc.
Jun 18, 2019 Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm... Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the re... Class II Howmedica Osteonics Corp.
Jun 18, 2019 Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... Mislabeled - The product's labeling contains an incorrect size for the catheter included in the k... Class II Epimed International, Inc.
Jun 18, 2019 Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrode... Supplemental information provided with devices indicates that the subdural electrodes, depth elec... Class II Ad-Tech Medical Instrument Corporation
Jun 18, 2019 LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized ... On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 a... Class II Ad-Tech Medical Instrument Corporation
Jun 18, 2019 DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which... Class II DeRoyal Industries Inc
Jun 18, 2019 Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Elec... Supplemental information provided with devices indicates that the subdural electrodes, depth elec... Class II Ad-Tech Medical Instrument Corporation
Jun 18, 2019 Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... Mislabeled - The product's labeling contains an incorrect size for the catheter included in the... Class II Epimed International, Inc.
Jun 17, 2019 Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For card... If battery maintenance is not performed appropriately, the battery may provide less than the mini... Class I Datascope Corp.
Jun 17, 2019 CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiova... If battery maintenance is not performed per instructions, the battery may provide less than the m... Class I Datascope Corp.
Jun 17, 2019 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For card... Battery short-run times and unanticipated stoppage may be due to user not performing battery main... Class I Datascope Corp.
Jun 17, 2019 da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601... One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. Th... Class II Intuitive Surgical, Inc.
Jun 17, 2019 CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiova... If battery maintenance is not performed per instructions, the battery may provide less than the m... Class I Datascope Corp.
Jun 17, 2019 CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiova... If battery maintenance is not performed appropriately, the battery may provide less than the mini... Class I Datascope Corp.
Jun 17, 2019 CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiova... If battery maintenance is not performed appropriately, the battery may provide less than the mini... Class I Datascope Corp.
Jun 17, 2019 VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chem... Potentially Biased Results using VITROS Chemistry Products GLU Slides Class II Ortho-Clinical Diagnostics
Jun 14, 2019 EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741... Incorrect Peel-Apart Introducer Sheath in Kit. Class II Bard Peripheral Vascular Inc
Jun 14, 2019 Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only... Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class II Terumo Cardiovascular Systems Corporation
Jun 14, 2019 Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class II Terumo Cardiovascular Systems Corporation
Jun 14, 2019 Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750S... The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack ... Class II CooperSurgical, Inc.
Jun 14, 2019 Acuject Variable Injection Needle Potential for occluded injection needles. Class II Wilson-Cook Medical Inc.
Jun 14, 2019 EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)008017410... Incorrect Peel-Apart Introducer Sheath in Kit. Class II Bard Peripheral Vascular Inc
Jun 14, 2019 Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750S... The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack ... Class II CooperSurgical, Inc.
Jun 14, 2019 STANLEY Healthcare Arial 54315 Network Manager STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages... Class II Stanley Security Solutions Inc
Jun 14, 2019 Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to... Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class II Terumo Cardiovascular Systems Corporation
Jun 14, 2019 Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component Class II Terumo Cardiovascular Systems Corporation
Jun 14, 2019 Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with v... Device vented gas below the stated pressure. Class I TELEFLEX-MORRISVILLE
Jun 13, 2019 A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part ... There is a potential for the driver to bind up when attempting to advance the intervertebral body... Class II SpineFrontier, Inc.
Jun 12, 2019 Artis zee biplane MN, Model Number 10094143 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis dFC, Model Number 7412807 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis TC, Model Number 7728350 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tub... False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... Class II Becton Dickinson & Company
Jun 12, 2019 AXIOM Artis MP, Model Number 5904466 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis dBC, Model Number 5917054 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis FC, Model Number 5904433 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 AXIOM Artis BC, Model Number 5904649 A tolerance issue in the power supply of the generator control above a specific value may cause g... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2019 BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catal... False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... Class II Becton Dickinson & Company

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.