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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
May 31, 2019 REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear ... There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during t... Class II Baxter Healthcare Corporation
May 30, 2019 Anti-fog solution packaged in a Tyvek peel pouch and it is placed into variou... The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. Class II Medline Industries, Inc.
May 28, 2019 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage... Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class II Medline Industries Inc
May 28, 2019 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usag... Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class II Medline Industries Inc
May 28, 2019 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage:... Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class II Medline Industries Inc
May 24, 2019 ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for... Presence of a time dependent, stability drift in patient and control results returned from ARCHIT... Class III Abbott Laboratories
May 24, 2019 ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators ar... Presence of a time dependent, stability drift in patient and control results returned from ARCHIT... Class III Abbott Laboratories
May 23, 2019 E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is pl... E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Li... Class II Richard Wolf Medical Instruments Corp.
May 20, 2019 The Visibly Online Refractive Vision Test which is part of the Visibly Vision... Lack of 510K clearance Class II Opternative Inc
May 10, 2019 Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code ... This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to... Class I Medline Industries Inc
May 3, 2019 Leica Cryostats, used to produce frozen sample sections for biological, medic... The current labelling does not include any specific warning about usage of flammable freezing spr... Class II Leica Microsystems, Inc.
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

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.