Browse Device Recalls
806 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 806 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 806 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 8, 2026 | Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 | The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experien... | Class II | Fort Defiance Industries, LLC |
| Jun 30, 2026 | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas St... | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagemen... | Class II | restor3d Inc. |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 cou... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Produc... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Prod... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, ... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 26, 2026 | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short... | Class II | Erbe USA Inc |
| Jun 19, 2026 | munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control ... | A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When th... | Class II | MUNEVO GMBH |
| May 13, 2026 | Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Ang... | Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have par... | Class I | Medical Action Industries, Inc. 306 |
| May 13, 2026 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... | Due to 11 volt Backup Battery failures. | Class II | Thoratec LLC |
| May 11, 2026 | Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantab... | There is the potential for leakage along the drug pathway from the pump through the end of the ca... | Class II | Boston Scientific Corporation |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 20, 2026 | navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navif... | Due to complaints received for the Image Management System regarding image/metadata discrepancy w... | Class II | Ventana Medical Systems, Inc. |
| Apr 14, 2026 | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Mode... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). ... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Mod... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Mode... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extrav... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,K... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, ... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: TAV... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extrav... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: HEA... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 12, 2026 | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula ... | Class I | Insulet Corporation |
| Jan 8, 2026 | Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS ... | Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... | Class II | Medline Industries, LP |
| Jan 8, 2026 | Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHA... | Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... | Class II | Medline Industries, LP |
| Jan 8, 2026 | Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Me... | Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... | Class II | Medline Industries, LP |
| Jan 8, 2026 | Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS... | Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... | Class II | Medline Industries, LP |
| Jan 8, 2026 | Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG S... | Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... | Class II | Medline Industries, LP |
| Jan 8, 2026 | Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBS... | Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... | Class II | Medline Industries, LP |
| Dec 19, 2025 | VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 | There is a potential for formation of ice occurring in the venting system of the superconducting ... | Class II | Canon Medical System, USA, INC. |
| Dec 19, 2025 | VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 | There is a potential for formation of ice occurring in the venting system of the superconducting ... | Class II | Canon Medical System, USA, INC. |
| Dec 18, 2025 | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784... | Due to product that may contain a void in the material that separates the wire guide and cutting ... | Class II | Wilson-Cook Medical Inc. |
| Dec 11, 2025 | Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Ca... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 11, 2025 | Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog ... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 11, 2025 | The product is used for the evaluation of the intrinsic coagulation pathway, ... | Potential for microbial contamination. | Class II | Instrumentation Laboratory |
| Dec 11, 2025 | Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 11, 2025 | Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 8155... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 11, 2025 | Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog ... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 11, 2025 | Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: ... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 11, 2025 | Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 3, 2025 | SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR syst... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems wit... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
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.