Hologic Sizer Set- sterilization tray and 6 individual… recallZ-0669-2025 · Hologic, Inc · initiated Oct 10, 2022
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
FDA root cause category: Labeling Change Control
What the company is doing
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:[email protected]
Recall details
- Recall number
- Z-0669-2025
- Status
- Completed
- Initiated by the company
- Oct 10, 2022
- Posted by the FDA
- Dec 11, 2024
- Recalling firm
- Hologic, Inc
- Quantity
- 178 units
- Product code
- FZX
- Distribution
- US Nationwide distribution.
Product description
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Code information (models, lots, serial numbers)
Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sizer Set ASY-16190Hologic, Inc. · Guide, surgical, instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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