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
Aug 5, 2025 Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H749045... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 5, 2025 Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 5, 2025 Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 5, 2025 Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; ... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Jul 29, 2025 WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; i... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; in... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; ... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; i... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intend... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; in... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; i... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; in... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; in... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; ... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; in... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 24, 2025 ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardiover... Affected lead models may experience gradually rising LVSI measurements in association with calcif... Class I Boston Scientific Corporation
Jul 24, 2025 RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lea... Affected lead models may experience gradually rising LVSI measurements in association with calcif... Class I Boston Scientific Corporation
Jul 24, 2025 ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead,... Affected lead models may experience gradually rising LVSI measurements in association with calcif... Class I Boston Scientific Corporation
Jul 10, 2025 Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Ca... Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely in... Class II Beckman Coulter, Inc.
Jul 7, 2025 Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, s... Certain batches are being removed due to an increase in complaints received in which physicians e... Class I Boston Scientific Corporation
Jun 27, 2025 LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the ta... Class II Microbiologics Inc
Jun 27, 2025 LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pa... KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the ta... Class II Microbiologics Inc
Jun 25, 2025 UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... Class II Beckman Coulter, Inc.
Jun 25, 2025 UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... Class II Beckman Coulter, Inc.
Jun 25, 2025 DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... Class II Beckman Coulter, Inc.
Jun 25, 2025 FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 The potentially impacted units were manufactured using specific equipment that may have caused cr... Class II Boston Scientific Corporation
Jun 25, 2025 DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... Class II Beckman Coulter, Inc.
Jun 25, 2025 DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... Class II Beckman Coulter, Inc.
Jun 25, 2025 DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... Class II Beckman Coulter, Inc.
Jun 18, 2025 Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the fol... In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... Class II Medtronic, Inc.
Jun 18, 2025 Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the f... In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... Class II Medtronic, Inc.
Jun 17, 2025 KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 080... Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminu... Class II Microbiologics Inc
Jun 17, 2025 Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Mod... A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... Class II Medtronic, Inc.
Jun 17, 2025 Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Num... A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... Class II Medtronic, Inc.
Jun 10, 2025 VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VX... Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... Class II Boston Scientific Corporation
Jun 10, 2025 VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect i... Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... Class II Boston Scientific Corporation
Jun 10, 2025 VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J... Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... Class II Boston Scientific Corporation
Jun 10, 2025 Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F... Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... Class II Boston Scientific Corporation
May 27, 2025 KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K... Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product co... Class II Microbiologics Inc
May 22, 2025 IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; Io... The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to... Class II LTS Therapy Systems, LLC
May 22, 2025 IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; T... The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to... Class II LTS Therapy Systems, LLC
May 7, 2025 DxI 9000 Access Immunoassay Analyzer C11137 Analyzer has calibration issues where curves switched from passed to failed due to system errors ... Class II Beckman Coulter, Inc.
May 5, 2025 Access Testosterone assay, Catalog Number 33560 Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to s... Class II Beckman Coulter, Inc.
Apr 29, 2025 Azure S DR MRI SureScan, Product number W3DR01 Identified devices may experience sudden battery power failure without alarm, power supply power-... Class II Medtronic, Inc.
Apr 23, 2025 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... A new motor/encoder and cable was introduced into instruments manufactured starting with serial n... Class II Beckman Coulter, Inc.
Apr 23, 2025 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assa... Class II Beckman Coulter, Inc.
Apr 22, 2025 3M Ranger Irrigation Fluid Warming Set, REF 24750 Notice was issued to clarify flow rates related to the inlet fluid temperature. Class II 3M Company
Apr 10, 2025 CADD Solis HSPCA Pump Pumps may experience Wireless Connection Modules intermittent connection alarms, which will inter... Class I Smiths Medical ASD, Inc.
Apr 10, 2025 CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, ... There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. Class I Smiths Medical ASD, Inc.
Apr 10, 2025 CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VI... There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. Class I Smiths Medical ASD, 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.