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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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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

3,367 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,367 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 3,367 FDA device recalls in IL.

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DateProductReasonClassFirm
Jan 7, 2021 Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, ... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Dec 30, 2020 Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product ... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysi... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: i... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product c... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product c... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 28, 2020 FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 m... Potential for the battery to lose its ability to be recharged. Class II Baxter Healthcare Corporation
Dec 21, 2020 Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Need... There were customer reports of separation between the tubing and Male Luer Lock Adaptor. Class II Baxter Healthcare Corporation
Dec 15, 2020 WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to rel... The connection between the massager and heat element can overheat causing smoke or spark, which m... Class II Wahl Clipper Corp
Dec 11, 2020 VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction o... VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usa... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Pr... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 13, 2020 Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of c... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of con... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of conven... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type o... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 10, 2020 MiniCap Extended Life PD Transfer Set Potential for no-flow and leaks under the twist clamp. Class II Baxter Healthcare Corporation
Nov 5, 2020 RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressin... RevMedX Trauma Dressing is being recalled due to package seal integrity. Class II Medline Industries Inc
Oct 30, 2020 Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: ... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Num... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-0... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: ... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number:... Potential for a false-negative result. Class II Luminex Corporation
Oct 13, 2020 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a... Luminex has determined that three (3) separate test fixtures used by field service engineers to s... Class II Luminex Corporation
Oct 13, 2020 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a... Luminex has determined that three (3) separate test fixtures used by field service engineers to s... Class II Luminex Corporation
Oct 5, 2020 EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 The cross-reactivity of the device may present an increased level of potential false positives. S... Class II Thera Test Laboratories, Inc.
Oct 1, 2020 The Quidel Triage BNP Calibrators Product compromised during shipment. Class II Medline Industries Inc
Sep 15, 2020 Quick Release Gait Belt, 60 The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and I... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAM... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage:... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage:... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NA... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NA... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Us... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 1, 2020 ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL T... There have been reports of the suction catheter coming apart from the device assembly during use. Class II Medline Industries Inc
Aug 14, 2020 Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the de... This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have... Class II Siemens Medical Solutions USA, Inc.
Aug 12, 2020 Central Line Dressing Change Tray Potential of incomplete seals impacting the sterility of the kit. Class II Medline Industries Inc
Jul 30, 2020 EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not... Class II Thera Test Laboratories, Inc.
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC

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.