Hologic Sizer Set- sterilization tray and 6 individual sizers — Class II medical device recall Z-0669-2025
Completed recall by Hologic, Inc, reported 2024-12-18, distributed nationwide. IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
| Recall number | Z-0669-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2022-10-10 |
| Classified | 2024-12-11 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 178 units |
| UPC / GTIN / UDI-DI | 15420045515390 |
| Lot numbers | 140718-01, 162427, 171056, 175515, 175516, 175517, 186728, SS1-181121, SS1-190301, SS1-190501, SS1-200727 |
| Model numbers | F0101 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0669-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.