Browse Device Recalls

162 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 162 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 162 FDA device recalls.

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DateProductReasonClassFirm
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 Software issue that results in the display of outdated information.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.
Mar 24, 2025 Intera 1.5T Power/Pulsar, Model Number: 781105; 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 3.0T Quasar Dual, Model Number: 781150; 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 0.5T Standard, Model Number: 781101; 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 Omni/Stellar, Model Number: 781104; 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 Enterprise 1.5T, Model Number: 781145; 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 Omni/Stellar, Model Number: 781102; 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 SmartPath to dStream for 1.5T, Model Number: 782146; 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 Explorer/Nova Dual, Model Number: 781108; 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 SmartPath to dStream for 3.0T, Model Number: 782145; 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 Master/Nova, Model Number: 781106; 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.
Feb 28, 2025 Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; Multiple problems identified with the software version leading to various scanning and image issu... Class II Philips Medical Systems Nederland B.V.
Jan 13, 2025 Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281... Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20/20; Catalog numbers: 722038 Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD10C System Code: (1) 722001 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD10C; Catalog number: 722001 Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20/10; Catalog numbers: 722029 Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20/20 System Code: (1) 722038 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 5 M12 System Code: (1) 722227 (2) 722231 Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... 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.