Class IICompletedZ-2115-2025
Beckman Coulter, Inc. recalls Access Vitamin B12 Reagent
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850.…
Beckman Coulter, Inc.MNJul 23, 2025
Recalls in Minnesota
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 145–156 of 233 recalls
Class IIOngoingZ-2106-2025
Boston Scientific Corporation recalls Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DE…
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario.…
Boston Scientific Corp…MNJul 16, 2025
Class IIOngoingZ-2105-2025
Boston Scientific Corporation recalls VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45D…
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario.…
Boston Scientific Corp…MNJul 16, 2025
Class IIOngoingZ-2104-2025
Boston Scientific Corporation recalls VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the hear…
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario.…
Boston Scientific Corp…MNJul 16, 2025
Class IIOngoingZ-2103-2025
Boston Scientific Corporation recalls VersaCross Access Solution (VXSK)
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario.…
Boston Scientific Corp…MNJul 16, 2025
Class IIOngoingZ-1996-2025
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer C11137
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed.…
Beckman Coulter, Inc.MNJul 2, 2025
Class IIOngoingZ-1957-2025
Microbiologics Inc recalls KWIK-STICK
Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs.…
Microbiologics IncMNJun 18, 2025
Class IIOngoingZ-1926-2025
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly.…
Beckman Coulter, Inc.MNJun 18, 2025
Class IIOngoingZ-1924-2025
Medtronic, Inc. recalls Azure S DR MRI SureScan
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy.…
Medtronic, Inc.MNJun 18, 2025
Class IIOngoingZ-1913-2025
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Beckman Coulter, Inc.MNJun 11, 2025
Class IIOngoingZ-1901-2025
Beckman Coulter, Inc. recalls Access Testosterone assay
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result i…
Beckman Coulter, Inc.MNJun 11, 2025
Class IOngoingZ-1682-2025
Smiths Medical ASD, Inc. recalls CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Smiths Medical ASD, In…MNMay 14, 2025