Z-0669-2025Class II

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide...

Name: Z-0669-2025 Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide...
Creator: Hologic, Inc
Published: 2022-10-10
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2022-10-10 / Completed / root cause: labeling and UDI

FDA source

Hologic, Inc began a recall of Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101 on 2022-10-10. FDA classified it as Class II and gives the reason as "IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0669-2025
Classification: Class II
Status: Completed
Initiated: 2022-10-10
Posted: 2024-12-11
Recalling firm: Hologic, Inc.
Product: Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Product code: FZX Guide, Surgical, Instrument
Reason for recall: IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Root cause tag: labeling and UDI
FDA 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:[email protected]
Quantity in commerce: 178 units
Distribution: US Nationwide distribution.
Product codes and lots: Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0669-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0669-2025	Class II	Completed	Voluntary: Firm initiated	2024-12-18	2024-12-11

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)