FDA Device recall Z-0669-2025
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
- FDA Device
- Class II
- completed
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101 by Hologic, citing IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0669-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-10-10 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hologic |
| Distribution | US |
Product
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Reason
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Identifiers
| code_info | Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0669-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.