---
title: "Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a ... — FDA record Z-0669-2025 | Is It on Recall"
description: "IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set"
url: https://isitonrecall.com/recall/fda-device-z-0669-2025-hologic-sizer-set-sterilization-tray-and-6-individual-sizers-intended-as-a-surgical-instrument-guide/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog ... — FDA record Z-0669-2025

Reported completed

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 10, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
- **Reason**: IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
- **Classification**: Class II
- **Recalling firm**: Hologic, Inc
- **Quantity**: 178 units
- **Agency-reported status**: Completed
- **Source record identifier**: Z-0669-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0669-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alaska](https://isitonrecall.com/state/alaska/)
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- [Colorado](https://isitonrecall.com/state/colorado/)
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- [Hawaii](https://isitonrecall.com/state/hawaii/)
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- [Idaho](https://isitonrecall.com/state/idaho/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
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- [North Dakota](https://isitonrecall.com/state/north-dakota/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [New Hampshire](https://isitonrecall.com/state/new-hampshire/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
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- [Nevada](https://isitonrecall.com/state/nevada/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Rhode Island](https://isitonrecall.com/state/rhode-island/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Vermont](https://isitonrecall.com/state/vermont/)
- [Washington](https://isitonrecall.com/state/washington/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)
- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: Dec 18, 2024
- **Recall initiation date**: Oct 10, 2022
- **Center classification date**: Dec 11, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0669-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Hologic, Inc records](https://isitonrecall.com/brand/hologic-inc/)