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.

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DateProductReasonClassFirm
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
Jul 18, 2024 smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) RE... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 smiths medical portex, Y' PIECE 15MM, REF 100/276/000 Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY ... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Mate... 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 smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M00... 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 VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M0012453... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jul 16, 2024 CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also ... Damage to the battery pack may have caused a short to a capacitor within the battery pack. While... Class I Smiths Medical ASD Inc.
Jul 12, 2024 DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagn... Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially ... Class II Beckman Coulter, Inc.
Jul 11, 2024 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Produ... Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential ... Class II Medtronic Inc.
Jul 10, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RS... Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatic... Class II Beckman Coulter, Inc.
Jul 9, 2024 Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrect... Class II Medtronic Perfusion Systems
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model... The adapter input plug can become damaged or broken. If the input plug is damaged, the metal con... Class II Smiths Medical ASD, Inc.
Jun 26, 2024 ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code... Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II 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.