Browse Device Recalls

740 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 740 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 740 FDA device recalls.

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DateProductReasonClassFirm
Sep 3, 2025 Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated... 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; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Ass... 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; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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 FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Assoc... 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 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035... 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 OR Table; Model Numbers: 722059; 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 Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: ... 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; Product Code: 722039; 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 FD20/20; Model Numbers: 722038; 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 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated... 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 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; A... 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 CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K1306... 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 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; A... 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 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated... 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 FD10C; Model Number: 722001; Associated 510(k)s: K102005, K1306... 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 CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K13084... 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 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

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.