FDA Medical Device Recalls (openFDA)
Hologic, Inc: Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
- Recall number
- Z-0669-2025
- Recalling firm
- Hologic, Inc
- Product
- Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
- Status
- Completed
- Initiated
- 2022-10-10
- Posted
- 2024-12-11
- Terminated
- not on file
- Reason
- IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
- Root cause
- Labeling Change Control
- Action
- Hologic issued Letter-Revised Sterilization Instructions for Sizer Set on 10/10/22 via Fed'X. The letter states reason for recall, health risk and action to take: Effective immediately, please steam autoclave F0101 in accordance with such IFU, subject to the following parameters. Any additional parameters contained in Hologic s IFU for F0101 should no longer be utilized. link to their Instructions for Use (IFU) below: https://summitmedicalusa.com/wordpress/wp-content/uploads/2021/05/40192-01_RevZ_IS-IFU_Multilingual.pdf Please also note that when sterilizing F0101, one (1) layer of wrapping material (or one layer of 1 ply wrap) is necessary to provide a sterile barrier for each sterilization tray. Please do not utilize 2 layers or one layer of 2-ply wrap. In the future, Hologic will be updating the IFU supplied with the sizers within F0101, to reflect this change. mailto:BreastHealth.Support@hologic.com
- Quantity
- 178 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZX
- Firm FEI
- 1000120743
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28