Browse Device Recalls
34,608 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,608 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 34,608 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 | 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 | eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 | 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 | eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 | 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 | eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 | 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 | eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 | 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 | eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. ... | Class II | Civco Medical Instruments Co. Inc. |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... | Unapproved design changes to the products outside of the 510(k) clearance. | Class II | Medline Industries, LP |
| Feb 27, 2026 | Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor | Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (C... | Class II | Spacelabs Healthcare, Inc. |
| Feb 27, 2026 | Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1... | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Sy... | Class II | Cardinal Health 200, LLC |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTI... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: S... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
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.