Class II
Medical Device Recall: Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Hologic, Inc · October 10, 2022
Reason for Recall
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
178 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0669-2025
Status: completed
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