Browse Device Recalls

1,674 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,674 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 1,674 FDA device recalls in MN.

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DateProductReasonClassFirm
Aug 6, 2026 ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Number... The linear actuator and rotational lock mechanism components may experience a mechanical failure ... Class II IMRIS Imaging Inc
Aug 6, 2026 ORT200, operating room table, including the ORT200 Covered Table Assembly, Re... The linear actuator and rotational lock mechanism components may experience a mechanical failure ... Class II IMRIS Imaging Inc
Jul 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Numb... Potential for arterial sheath tip separation or partial tip separation during use. Class I Boston Scientific Corporation
Jul 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material... Potential for arterial sheath tip separation or partial tip separation during use. Class I Boston Scientific Corporation
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 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 11, 2026 FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vas... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vascul... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vascul... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablat... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutan... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that i... Class II Boston Scientific Corporation
Jun 11, 2026 FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculatur... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
May 25, 2026 Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010;... Medtronic received two complaints of loose foreign material confirmed as containing trace levels ... Class II Medtronic Perfusion Systems
May 25, 2026 Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardio... Medtronic received two complaints of loose foreign material confirmed as containing trace levels ... Class II Medtronic Perfusion Systems
May 13, 2026 Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 13, 2026 Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 12, 2026 Octopus Evolution Tissue Stabilizer, Model TS2000 During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... Class II Medtronic Perfusion Systems
May 12, 2026 Octopus 4 Tissue Stabilizer, Model 29400 During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... Class II Medtronic Perfusion Systems
May 12, 2026 Octopus Evolution AS Tissue Stabilizer, Model TS2500 During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... Class II Medtronic Perfusion Systems
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
May 11, 2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory ... Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... Class II Inspire Medical Systems Inc.
May 11, 2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation ... Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... Class II Inspire Medical Systems Inc.
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Mode... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Mo... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 8, 2026 Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode,... Class II Medtronic Neuromodulation
Mar 30, 2026 LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATI... For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM dev... Class II Boston Scientific Corporation
Mar 30, 2026 LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE ... For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM dev... Class II Boston Scientific Corporation
Mar 19, 2026 Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Car... Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... Class I Boston Scientific Corporation
Mar 19, 2026 Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VA... Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... Class I Boston Scientific Corporation
Mar 16, 2026 Flamingo Funnel Large, Model Number SQ20012-03 Certain lots of product were associated with a manufacturing nonconformance involving use of a no... Class II SurgiSmoke Solutions
Mar 16, 2026 Flamingo Funnel Medium, Model Number SQ20012-02 Certain lots of product were associated with a manufacturing nonconformance involving use of a no... Class II SurgiSmoke Solutions
Mar 16, 2026 Access Total T4 Calibrator, Catalog No. 33805 Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative... Class II Beckman Coulter, Inc.
Mar 16, 2026 Flamingo Funnel Small, Model Number SQ20012-01 Certain lots of product were associated with a manufacturing nonconformance involving use of a no... Class II SurgiSmoke Solutions
Mar 11, 2026 Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... Class II Medtronic, Inc.
Mar 5, 2026 Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small,... Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatibl... Class II Tornier, 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.