Browse Device Recalls

1,624 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,624 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 1,624 FDA device recalls in MN.

Clear

Date	Product	Reason	Class	Firm
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
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), RE...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (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
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H7490...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), RE...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H7...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H7...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H749...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (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
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H7490...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H749...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H749...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H749...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), RE...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749...	An increase in complaints related to an inability to advance the guidewire through the lumen of t...	Class I	Boston Scientific Corporation
Mar 21, 2024	Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H7...	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.