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
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK N... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE,... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PAC... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe... Class II Baxter Healthcare Corporation
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAP... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) T A PACK, Model N... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK P... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GEN... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP P... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Mo... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Mod... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Nu... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 25, 2025 Baxter Mobile column TruSystem 7500, Product Code 1717023 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Floor mounting column TS 7500 U, Product Code 1730732 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Floor mounting column TruSystem 7500, Product Code 1717021 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or ... The air bladders inside the mattress may move out of position when the head of the bed is elevate... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Stationary column TruSystem 7500 U, Product Code 1730731 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Stationary column TruSystem 7500, Product Code 1717020 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500, Product Code 4091000 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Mobile column TruSystem 7500 U, Product Code 1730720 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 24, 2025 Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, ... Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medline medical procedure kits, containing Medtronic Aortic Root Cannula Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 19, 2025 Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCL... There is a potential for the sterility of the device to be compromised. Class II 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.