Class IIOngoingZ-2107-2025
Preat Corp recalls Preat
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Preat CorpCAJul 16, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,513–1,524 of 2,908 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-2101-2025
Medtronic Navigation, Inc.-Boxborough recalls O-arm O2 Imaging System. Mobile X-Ray System.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Medtronic Navigation,…MAJul 16, 2025
Class IIOngoingZ-2100-2025
Neurovision Medical Products Inc recalls Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Ca…
Product packaging contains the wrong part number and kit contents.
Neurovision Medical Pr…CAJul 16, 2025
Class IIOngoingZ-2099-2025
Canary Medical, Inc. recalls Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number:…
Due to labeling error. Product incorrectly labeled.
Canary Medical, Inc.CAJul 16, 2025
Class IIOngoingZ-2098-2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Varicam
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed.…
GE MEDICAL SYSTEMS ISR…Jul 16, 2025
Class IIOngoingZ-2097-2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Infinia
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed.…
GE MEDICAL SYSTEMS ISR…Jul 16, 2025
Class IIICompletedZ-2094-2025
STRATASYS LTD recalls TrueDent White
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month.…
STRATASYS LTDJul 16, 2025
Class IIICompletedZ-2093-2025
STRATASYS LTD recalls TrueDent Yellow
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month.…
STRATASYS LTDJul 16, 2025