Browse Device Recalls

1,646 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,646 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 1,646 FDA device recalls in MN.

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DateProductReasonClassFirm
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRAC... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TU... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEO... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEON... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCU... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Cod... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 22, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoas... Class II Beckman Coulter, Inc.
May 22, 2024 DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) ... Class II Beckman Coulter, Inc.
May 16, 2024 Inspire Model 3028, IV Implantable Pulse Generator There is a potential manufacturing defect which can lead to electrical leakage in the sensing cir... Class I Inspire Medical Systems Inc.
May 16, 2024 TourniKwik Tourniquet Set (CFN 79012) Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. Class II Medtronic Perfusion Systems
May 15, 2024 A610 Clinician Programmer (CP) Software Application (app) with the following ... Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI ... Class II Medtronic Neuromodulation
May 10, 2024 Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 878... Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of th... Class II Medtronic Neuromodulation
Apr 30, 2024 St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 One lot of product has dilators that are too short and will not extend outside the introducer she... Class II St. Jude Medical
Apr 22, 2024 muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including ... During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital s... Class II Murata Vios, Inc.
Apr 18, 2024 Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitr... When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is co... Class II Beckman Coulter, Inc.
Apr 18, 2024 DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic ... Class II Beckman Coulter, Inc.
Apr 16, 2024 EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defib... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardi... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defib... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardiover... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardiover... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardi... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Product not distributed in the US. Implantable Cardioverter Defibrillators: ... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardiover... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Def... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Def... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardiove... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defib... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Mar 28, 2024 Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator inability to reprogram one device Class II Medtronic Neuromodulation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation

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.