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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

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

Clear
DateProductReasonClassFirm
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 29, 2019 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... Class II ICU Medical Inc
Jul 1, 2019 Erisma- LP posterior fixation system with the below specifically affected pro... Potential for the polyaxial screw to become disassembled during implant. Class III Clariance Inc
Jun 27, 2019 EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 P... EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. Class III Baxter Healthcare Corporation
Jun 24, 2019 VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1... The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri... Class I Fenwal Inc
Jun 24, 2019 Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Prod... The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri... Class I Fenwal Inc
May 31, 2019 REVACLEAR 300 Dialyzer, Product Code 114745L 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 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.

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.