Browse Device Recalls
905 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 905 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 905 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 03... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100C... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU ... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 0... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACC... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100C... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65C... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 03... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; A... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 03... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Marker... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO | Due to increased in complaints their is the potential for endoscopic clipping device to malfunct... | Class II | Wilson-Cook Medical Inc. |
| Mar 3, 2026 | ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Allura Xper FD10C; System Code: 722001; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS o... | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Allura Xper FD20/20; System Code: 722038; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Allura Xper FD20/15; System Code: 722058; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Allura Xper FD20/20 OR Table; System Code: 722039; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS O... | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Allura Xper FD20/10; System Code: 722029; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | ALLURA Xper FD10F; System Code: 722002; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria ide... | Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A l... | Class II | Oxoid Australia Pty Limited |
| Mar 3, 2026 | Azurion 5 M12; System Code: (1)722227, (2)722231; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | Allura Xper FD20/15 OR Table; System Code: 722059; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 3, 2026 | ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. ... | Class II | Civco Medical Instruments Co. Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. ... | Class II | Civco Medical Instruments Co. Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
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.