Browse Device Recalls

201 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 201 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 201 FDA device recalls.

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DateProductReasonClassFirm
Dec 15, 2025 Allura Xper FD10; Model Number: 722003; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Product Name: Allura Xper FD10C; Model number: 722001; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20; Model Number: 722028; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10/10; Model Number: 722027; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10F; Model Number: 722002; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 12, 2025 Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes ... Six (6) identified software issues which may result in the following: system keeps restarting, AM... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 12, 2025 Philips Azurion system; Software Version Number: R3.1; Philips has identified two (2) software issues affecting device systems that may result in loss o... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 8, 2025 Philips Azurion Systems R3.0. Includes the following label descriptions and c... Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Oct 2, 2025 Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Numb... The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eve... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 29, 2025 Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray... Over time some systems may experience loss of imaging functionality and/or poor image quality due... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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 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 8, 2025 IntelliSpace Cardiovascular, Software 8.0.0.4. Software issue that results in the display of outdated information. Class II Philips Medical Systems Nederland B.V.
Aug 1, 2025 Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labele... Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 1, 2025 Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.... Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 1, 2025 Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R... Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 30, 2025 Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD... Potential for temporary loss of imaging (X-ray) functionality due to software issue. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 4, 2025 Azurion 7 M20. Fluoroscopic X-Ray System. Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 28, 2025 Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 72... A software issue was identified in the internal communication process between the system softwar... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 7, 2025 IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number... An issue was identified with the software when using the Echo Module of ISCV, the issue may resul... Class II Philips Medical Systems Nederland B.V.
Mar 24, 2025 Intera CV, Model Number: 781107; The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 24, 2025 Intera 1.0T Power/Pulsar, Model Number: 781103; The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 24, 2025 Intera 1.5T, Model Numbers: 781195 and 781295; The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 24, 2025 Intera 1.5T R11, Model Number: 781170; The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... 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.