Hologic, Inc Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Brand
Hologic, Inc
Lot Codes / Batch Numbers
Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
Products Sold
Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
Hologic, Inc is recalling Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument gui due to IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026