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FDAOctober 10, 2022device

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set

What to do

FDA enforcement status: Completed

Brands named

hologic

UPCs

15420045515390

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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