Browse Device Recalls

723 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 723 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 723 FDA device recalls.

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DateProductReasonClassFirm
Sep 3, 2025 Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K1020... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K1... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K1... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K1... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associ... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 51... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associa... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 20, 2025 ACCOLADE DR SL MRI (Model L311) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number S722, ALTRUA 2 DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 PROPONENT DR SL (Model L201) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE SR SL MRI (Model L310) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L100, ESSENTIO SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U125, VALITUDE CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE SR SL (Model L300) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L111, ESSENTIO DR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number S701 ALTRUA 2 SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR EL (Model L321) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR SL (Model L301) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L210 PROPONENT SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U225 VISIONIST CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L110, ESSENTIO SR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR EL MRI (Model L331) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L131, ESSENTIO DR EL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U228, VISIONIST CRT-P EL MRI Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L101, ESSENTIO DR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L231, PROPONENT DR EL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U128, VALITUDE CRT-P EL MRI Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L211 PROPONENT DR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L121 ESSENTIO DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L221 PROPONENT DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 PROPONENT SR SL (Model L200) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U226, VISIONIST CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L209 PROPONENT DR (VDD) SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number S702, ALTRUA 2 DR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Jul 21, 2025 Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF:... Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16")... Class I Tandem Diabetes Care, Inc.
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec LLC
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec LLC
Jun 18, 2025 Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator withou... Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... Class II Stryker Corporation
Jun 18, 2025 Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Di... Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... Class II Stryker Corporation
Apr 29, 2025 Azure S DR MRI SureScan, Product number W3DR01 Identified devices may experience sudden battery power failure without alarm, power supply power-... Class II Medtronic, Inc.
Mar 24, 2025 Welch Allyn CP150 Electrocardiograph: There were customer reports of devices which experienced battery-related fires. The investigation... Class II Baxter Healthcare Corporation
Mar 24, 2025 Welch Allyn CONNEX Accessory Power Management Stand: There were customer reports of devices which experienced battery-related fires. The investigation... Class II Baxter Healthcare Corporation
Mar 24, 2025 Welch Allyn Connex Vital Signs Monitor (CVSM): There were customer reports of devices which experienced battery-related fires. The investigation... Class II Baxter Healthcare Corporation
Mar 21, 2025 Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 Drill for use in neurosurgical procedures may have a reverse battery orientation, which may incre... Class II Phasor Health, LLC
Mar 6, 2025 Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number ... The battery for certain ultrasound systems can potentially develop an internal failure which coul... Class II GE Medical Systems, LLC
Mar 6, 2025 Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (... The battery for certain ultrasound systems can potentially develop an internal failure which coul... Class II GE Medical Systems, LLC
Mar 5, 2025 HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 Due to incorrect the battery charger being packaged and distributed. Product labeling does not m... Class II Advanced Bionics, 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.