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
Sep 24, 2024 medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex Arterial Kit 1/EA, Product Code REF MX7827 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 18, 2024 Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components... The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. Class II Medtronic Neuromodulation
Sep 16, 2024 The Graft Tube is an optional instrument which, as designed, can be filled wi... Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used a... Class II Spineology, Inc.
Sep 12, 2024 iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intende... Incorrect GTIN number. Class III Iotamotion Inc
Sep 11, 2024 SynchroMed II Infusion Pump. Product Number: 8637-20 Potential for error and inability to interrogate pump due to data corruption in the pump memory. Class II Medtronic Neuromodulation
Sep 6, 2024 Boston Scientific myLUX Patient Application for an Apple Mobile device, Mode... Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhon... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO I... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use... IFUs for the device incorrectly states the biotin interference was remediated. The issue could r... Class II Beckman Coulter, Inc.
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Aug 29, 2024 Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, f... Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled u... Class II Tornier, Inc
Aug 29, 2024 stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DW... One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max... Class II Tornier, Inc
Aug 28, 2024 The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent im... Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hor... Class II Beckman Coulter, Inc.
Aug 21, 2024 Vanta Implantable Neurostimulator (INS), Model 977006 Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading t... Class II Medtronic Neuromodulation
Aug 14, 2024 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R Contamination with foreign substance matter Class II 3M Company - Health Care Business
Aug 9, 2024 Vios Monitoring System Bedside Monitor Model BSM2050 Batteries may deplete over time while not in use if devices are stored without being plugged in t... Class II Murata Vios, Inc.
Jul 31, 2024 Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway St... Labeling error with a mismatch between the shelf box serial number label and the serial number of... Class II Inspire Medical Systems Inc.
Jul 31, 2024 Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper A... Labeling error with a mismatch between the shelf box serial number label and the serial number of... Class II Inspire Medical Systems Inc.
Jul 26, 2024 BiomarC EX Fiducial Marker System, Catalog Number 040165 This recall has been initiated due to a failure to provide an MRI Insert that is to be provided t... Class III Carbon Medical Technologies, Inc.
Jul 18, 2024 smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; ... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jul 18, 2024 Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II 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.