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.

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DateProductReasonClassFirm
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
Dec 6, 2023 Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 9340... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG04... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the fo... 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 NL, 5 mL, Product Codes: ADS201883 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 (US), Product Codes: a) VG0108: 0.8 X... 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 Fast Prep, Product Codes: a) ADS201844, 5 m... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 6, 2023 Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100,... Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... Class II Baxter Healthcare Corporation
Dec 4, 2023 Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DR... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE,... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC,... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRA... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, ... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 TRACH KIT W/HYDROGEN & SALI Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PRO... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Nov 29, 2023 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2... Surgical gowns were manufactured with the wrong sleeve. Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield

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.