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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

3,306 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,306 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 3,306 FDA device recalls in IL.

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DateProductReasonClassFirm
May 3, 2019 Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warm... The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum leve... Class I Medline Industries Inc
Apr 25, 2019 Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: T... Potential risk of brush detachment during cleaning. If brush detachment is not identified, there... Class II Medline Industries Inc
Apr 22, 2019 Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R Two of three complaints were initiated due to the customers repeatedly obtaining No Call results ... Class II Luminex Corporation
Apr 12, 2019 Posey Connected Twice-As-Tough Cuffs Not meeting design specifications. Class II TIDI PRODUCTS
Apr 9, 2019 ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calib... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Cali... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators ... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assaye... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHIT... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assaye... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibr... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The AR... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Ca... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Mar 13, 2019 enFlow Disposable Cartridge with IV Extension Set, used for intravenous warmi... Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warm... Class I Vyaire Medical
Mar 13, 2019 enFlow Disposable Cartridge, used for intravenous warming therapy with fluid ... Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. Class I Vyaire Medical
Mar 5, 2019 Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled ... Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events invo... Class II Fenwal Inc
Feb 11, 2019 Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autot... The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" d... Class II Fenwal Inc
Jan 31, 2019 Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR... Potential for the Semi-Rigid canister lid to fragment during use. Class II Medline Industries Inc
Jan 2, 2019 Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope... The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. Class II Leica Microsystems, Inc.
Dec 18, 2018 Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga ... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical i... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical inst... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instr... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product ... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 11, 2018 AMIA Automated Peritoneal Dialysis System Product Usage: It is intended ... Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... Class II Baxter Healthcare Corporation
Dec 11, 2018 Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended... Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... Class II Baxter Healthcare Corporation
Dec 5, 2018 Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 The sterility may be compromised due to a potential breach in the packaging, even though it may a... Class III Medela Inc
Dec 5, 2018 Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, include... A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged S... Class II Sage Products Inc
Nov 30, 2018 Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biogr... Improper design or specifications. Class II Siemens Medical Solutions USA, Inc.
Nov 8, 2018 SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 I... There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow... Class II ICU Medical Inc
Nov 2, 2018 GEM Coupler Forceps, GEM4183C, packaged individually. Potential presence of rust on Coupler Forceps (GEM4183C). Class II Baxter Healthcare Corporation
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile ligh... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glov... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 10, 2018 L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic f... Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of... Class II Baxter Healthcare Corporation
Oct 5, 2018 EVO Excel, Emission Computed Tomographic System, Material Number 10910501 The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be l... Class II Siemens Medical Solutions USA, Inc.
Sep 28, 2018 Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 105... The terminals on the plug may become loose and overheat. Class II Siemens Medical Solutions USA, Inc.
Sep 28, 2018 Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material... The terminals on the plug may become loose and overheat. Class II Siemens Medical Solutions USA, Inc.
Sep 17, 2018 BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with... The power supply unit for the printer used with the device can potentially overheat or cause a fi... Class II Leica Microsystems, Inc.
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used t... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation

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.