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.

Clear
DateProductReasonClassFirm
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.
Jan 13, 2025 AlluraXperFD20/15 System Code: (1) 722058 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 OR Table System Code: (1) 722023 (2) 722035 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; Catalog numbers: (1) 722227, (2) 722231 (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 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 ... 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 FD20/15; Catalog numbers: 722058 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 FD20 Biplane System Code: (1) 722008 (2) 722013 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 AlluraXperFD20/10 System Code: (1) 722029 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 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025. 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; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. 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 FD20 System Code: (1) 722006 (2) 722012 (3) 722028 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 System Code: (1) 722068 (2) 722226 (3) 722236 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 CV20 System Code: 722031 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 B12 System Code: (1) 722067 (2) 722225 (3) 722235 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 3 M12; Catalog numbers: (1) 722063, (2) 722221. 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 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 72228... 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 CV20; Catalog numbers: 722031 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; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(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 FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. 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 M12 System Code: (1) 722063 (2) 722221 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.