Browse Device Recalls
685 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 685 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 685 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 26, 2026 | Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Softwa... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Sof... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version ... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Soft... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)7222... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Softwa... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Allura Xper FD20; Model Number: 722006; | 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; Model Number: 722026; | 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 Biplane; Model Number: 722013; | 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 OR Table; Model Number: 722023; | 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 Biplane; Model Number: 722008; | 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; Model Number: 722010; | 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 FD20/10; Model Number: 722029; | 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: 722012; | 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: 722005; | 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 FD20/20; Model Number: 722038; | 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: 722011; | 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; 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. |
| Oct 1, 2025 | DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 71... | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | CombiDiagnost R90; Model Number: 709031; | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | ProxiDiagnost N90; Model Number: 706110; | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | Precision CRF; Model Number: 706400; | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Num... | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | Radiography 7300 C; Model Number: 712037; | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| 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 25, 2025 | Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Ve... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 25, 2025 | Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 25, 2025 | Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Ver... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| 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. |
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.