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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

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 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 474 FDA device recalls.

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DateProductReasonClassFirm
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, ... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single S... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Mar 28, 2018 Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a)... products may be missing a one-way valve on the fluid patient port. Class II Cardinal Health 200, LLC
Feb 20, 2018 Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML d... A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... Class II Cardinal Health 200, LLC
Feb 20, 2018 Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 50... A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... Class II Cardinal Health 200, LLC
Feb 20, 2018 Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric ... A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... Class II Cardinal Health 200, LLC
Feb 20, 2018 Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML dev... A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... Class II Cardinal Health 200, LLC
Aug 1, 2017 Presource(R) Kits (custom surgical/procedural kits): The standard and custom... The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i... Class II Cardinal Health 200, LLC
Jul 28, 2017 Convertors Robotic Drape with Attached Leggings; Product is packaged as Singl... Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings. Class II Cardinal Health 200, LLC
Jun 27, 2017 Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STE... Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ... Class II Cardinal Health 200, LLC
Jun 27, 2017 Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Car... Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Si... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Si... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Sin... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use On... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For S... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single U... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Sin... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Oct 6, 2016 The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, infla... AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device ... Class II AccessClosure, Inc., A Cardinal Health Company
Sep 23, 2016 V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, vario... Potential risk associated with corrosion demonstrated on the distraction screw surface. Class II Cardinal Health 200, LLC
Jul 20, 2016 BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, ... Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specif... Class II Cardinal Health
Jul 13, 2016 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usa... A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/pa... Class II AccessClosure, Inc., A Cardinal Health Company
Jun 27, 2016 The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sam... Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as mi... Class II Cardinal Health
Jun 22, 2016 Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Feb 29, 2016 Gomco Style Circumcision Clamp Trays is an instrument used to compress the fo... Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumci... Class II Cardinal Health
Nov 20, 2015 Cardinal Health Tiny Toes; 11470-010T Infant heel warmer Heel warmers may cause first and second degree burns. Class II Philips Electronics North America Corporation
Aug 25, 2015 Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal... Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commer... Class II Cardinal Health
Dec 23, 2014 Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube t... A small piece of the stylet sheath has the potential to shear off upon removal of the stylet fro... Class II Cardinal Health
Sep 17, 2014 Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is ... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, ... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, 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.