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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.