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
Feb 1, 2024 In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, R... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Jan 31, 2024 Trumpet, Needle Guide, Cat# TMS-200 The Ring on the Trump Needle Guide can detach when excessive pressure is applied. Class II Technicality Inc.
Jan 23, 2024 CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate packa... Product failed sterility testing. Class II MEDLINE INDUSTRIES, LP - Northfield
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... Class I Vyaire Medical
Jan 10, 2024 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... Class I Vyaire Medical
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, withou... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... Class I Vyaire Medical
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... Class I Vyaire Medical
Jan 10, 2024 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, R... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... Class I Vyaire Medical
Jan 10, 2024 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Dete... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... Class I Vyaire Medical
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... Class I Vyaire Medical
Jan 10, 2024 AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, A... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... Class I Vyaire Medical
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... Class I Vyaire Medical
Jan 4, 2024 Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testin... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 28, 2023 Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000... Cardinal Health is expanding their previous product correction actions to a product removal of al... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777 Cardinal Health is expanding their previous product correction actions to a product removal of al... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection S... Cardinal Health is expanding their previous product correction actions to a product removal of al... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit... The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777 Cardinal Health is expanding their previous product correction actions to a product removal of al... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit C... The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, R... Cardinal Health is expanding their previous product correction actions to a product removal of al... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 Cardinal Health is expanding their previous product correction actions to a product removal of al... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For U... The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200... Cardinal Health is expanding their previous product correction actions to a product removal of al... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777 Cardinal Health is expanding their previous product correction actions to a product removal of al... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit ... The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... Class I Cardinal Health 200, LLC
Dec 28, 2023 Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection S... Cardinal Health is expanding their previous product correction actions to a product removal of al... Class I Cardinal Health 200, LLC
Dec 22, 2023 Baxter Exactamix Pro 2400, REF EXM24DY An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... Class I Baxter Healthcare Corporation
Dec 22, 2023 Baxter Exactamix Pro 1200, REF EXM12DY An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... Class I Baxter Healthcare Corporation
Dec 21, 2023 MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Caniste... The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... Class II Cardinal Health 200, LLC
Dec 21, 2023 Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Caniste... The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... Class II Cardinal Health 200, LLC
Dec 21, 2023 MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510 The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... Class II Cardinal Health 200, LLC
Dec 20, 2023 These wipes are saturated with 0.65% bleach solution. These wipes are antimic... There is stability concern for products dated with a 24-month shelf life. Product is safe and eff... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 8, 2023 XScribe Cardiac Stress Testing System, version 6, with below product names an... Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... Class II Baxter Healthcare Corporation
Dec 8, 2023 Q-Stress Cardiac Stress Testing System, version 6, with below product name / ... Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... Class II Baxter Healthcare Corporation
Dec 8, 2023 XScribe CP Cardiac Stress Testing System, version 6, with below product names... Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... Class II Baxter Healthcare Corporation
Dec 6, 2023 Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC12... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5m... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) P... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, ... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 15... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: ... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... 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.