Browse Device Recalls

35,226 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,226 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 35,226 FDA device recalls, Class II.

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DateProductReasonClassFirm
Jun 24, 2026 Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING ... Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40... Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failur... Class II Maquet Critical Care AB
Jun 24, 2026 EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with c... Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... Class II Medtronic Perfusion Systems
Jun 24, 2026 EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with... Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... Class II Medtronic Perfusion Systems
Jun 24, 2026 EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with c... Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... Class II Medtronic Perfusion Systems
Jun 24, 2026 EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary ... Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... Class II Medtronic Perfusion Systems
Jun 24, 2026 EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass a... Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... Class II Medtronic Perfusion Systems
Jun 24, 2026 EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with... Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... Class II Medtronic Perfusion Systems
Jun 24, 2026 Hotline Fluid Warming Set, single use device, is designed to warm blood and i... ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE F... Class II ICU Medical Inc.
Jun 23, 2026 Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-2... Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility a... Class II Arrowhead DE LLC
Jun 23, 2026 Charger for the Therabody Theragun, G4 PRO massage device, and products which... Charging cradle for the device may overheat while charging the device's removable battery pack, p... Class II Therabody, 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
Jun 19, 2026 Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M001... Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns t... Class II Boston Scientific Corporation
Jun 19, 2026 Power F2 Powered Fastening System, Product No. 0567091 Powered fastening sy... Product may experience accelerated roller wear and potential deformation due to interference betw... Class II Ferno-Washington Inc
Jun 17, 2026 Philips Allura under the following System Descriptions and corresponding mode... Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unaut... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 17, 2026 Philips Azurion under the following System Descriptions and corresponding mod... Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unaut... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 17, 2026 Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Inte... Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unaut... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 17, 2026 Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... Class II Freudenberg Medical, LLC
Jun 17, 2026 Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... Class II Freudenberg Medical, LLC
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pac... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr F... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KI... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tra... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cat... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerv... Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... Class II Windstone Medical Packaging, Inc.
Jun 17, 2026 P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped G... Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of... Class II Paragon 28, Inc.
Jun 17, 2026 Ventriculostomy Kit, REF: 46154 Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular... Class II Medtronic Neurosurgery
Jun 16, 2026 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235... Products may not have received adequate sterilization processing. Class II BD SWITZERLAND SARL
Jun 16, 2026 Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Softw... Due to a software issue within the WebApp that potentially prevents the user to overwrite the res... Class II Copan WASP
Jun 16, 2026 Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 Potential for unexpected instances where the front panel display turns off unexpectedly, and air ... Class II Olympus Corporation of the Americas
Jun 16, 2026 MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and misse... Class II Medtronic MiniMed, Inc.
Jun 16, 2026 Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... Class II Accuray Incorporated
Jun 16, 2026 Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... Class II Accuray Incorporated
Jun 15, 2026 One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. Devices could potentially be occluded or partially occluded. Class II Intersurgical Inc
Jun 15, 2026 One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway... Devices could potentially be occluded or partially occluded. Class II Intersurgical Inc
Jun 15, 2026 GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1... Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. Class II Terumo Medical Corporation
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... Class II TISSIUM SA
Jun 15, 2026 L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x ... Catheters, indicated for short/long-term peripheral access to central venous system for the admin... Class II Argon Medical Devices, Inc
Jun 15, 2026 L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 Catheters, indicated for short/long-term peripheral access to central venous system for the admin... Class II Argon Medical Devices, Inc
Jun 12, 2026 ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative m... The Test cup lot F level 1 low-quality control results values for the device were lower than expe... Class II Tosoh Bioscience 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.