FDA recall Z-0669-2025

Hologic, Inc · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Completed
Initiation date
2022-10-10
Report date
2024-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2025