Browse Device Recalls

2,817 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,817 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 2,817 FDA device recalls in 2025.

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DateProductReasonClassFirm
Sep 5, 2025 AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 Firm has identified a security vulnerability in AW Server products. If exploited, a malicious act... Class II GE Medical Systems, SCS
Sep 4, 2025 Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL L... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description RCEN25B ENT SDSC 024697... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MI... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Int... Carotid stent and post-dilation balloon system with integrated embolic protection system has an i... Class II Contego Medical LLC
Sep 4, 2025 Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 2... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item number/ Product description AKGN82E GENERA... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 XERF EFFECTOR 60. Electrosurgical unit. Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result... Class II Lutronic Corporation
Sep 4, 2025 Medical convenience kits Item Number/Description FHCP08Y C SECTION PK H... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GE... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK ... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Basic Biopsy Tray, Item Number NMBP44L Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits IHDC30R D AND C PACK Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item number/ Product description AHLD15X LABOR ... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMC... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description BFCT04X CATARACT PACK -... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHA... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 3, 2025 Allura Xper FD20/10; Product Code: 722029; 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 FD20/20; Product Code: 722038; 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 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 SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagno... Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail c... Class II Beckman Coulter Inc.
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 FlexLab (FLX) System. Potassium Test System. in vitro diagnostic The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis,... Class II Inpeco S.A.
Sep 3, 2025 FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysi... Class II Inpeco S.A.
Sep 3, 2025 Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. Potential issue that can cause the device to register "phantom" touches in the lower-left corner ... Class II Fresenius Kabi USA, LLC
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.

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.