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.

Clear
DateProductReasonClassFirm
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.