CLASS II Device recall · Reported 18 Dec 2024 · FDA Enforcement Report
Sizer Set- sterilization tray and 6 individual sizers recalled
Hologic is recalling Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument, distributed nationwide in the US. The recall was initiated on 10 Oct 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0669-2025
- FDA event ID
- 95781
- Recalling firm
- Hologic, Marlborough, MA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 10 Oct 2022
- FDA classified
- 11 Dec 2024
- Reported
- 18 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 10 Oct 2022 | Recall initiated by company | |
| 11 Dec 2024 | Classified by FDA | +793 days |
| 18 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Which lots are affected?
Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hologic
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 3dimensions Mammography System recalled by Hologic | Hologic | Other | Nationwide |
| Device | CLASS II | Selenia Dimensions Mammography Systems recalled by Hologic | Hologic | Other | Nationwide |
| Device | CLASS II | Genius" Review Station Display (Barco Monitor) recalled by Hologic | Hologic | Device Malfunction | Nationwide |
| Device | CLASS II | Aptima HPV Assay recalled by Hologic | Hologic | Potency & Assay | Nationwide |
| Device | CLASS II | Brevera Breast Biopsy System Disposable Needle recalled by Hologic | Hologic | Particulate Matter | Nationwide |
Other Surgical Instruments recalls
All 3,816| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical | Wilson-Cook Medical | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |