Hologic Sizer Set Sterilization Tray Recall: Missing Instructions Risk
Hologic recalls sterilization trays and sizers due to missing instructions. Owners should check model numbers and lot dates to determine if affected. No immediate action needed but ensure proper use.
Lower-risk recall
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Contact the company
What happened, in plain English
Hologic is recalling surgical instrument guides that lack sterilization instructions. This could lead to improper use if the user doesn't have the updated guidelines. Read more at govinfonow.com/recall/59928-hologic-sizer-set-sterilization-tray-recall-missing-instructions-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/59928-hologic-sizer-set-sterilization-tray-recall-missing-instructions-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0669-2025
Cite this page
“Hologic Sizer Set Sterilization Tray Recall: Missing Instructions Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/59928-hologic-sizer-set-sterilization-tray-recall-missing-instructions-risk. Based on FDA recall #Z-0669-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0669-2025%22&limit=1).
Why it’s dangerous
The product was sold without the updated sterilization instructions. Without these, users might not follow proper cleaning or sterilization procedures, potentially leading to contamination or infection risks.
Who’s affected
Surgical professionals and hospitals using the Hologic Sizer Set sterilization tray and 6 individual sizers are most at risk if they lack the revised sterilization instructions.
How to tell if you have this one
Check for model number F0101 and lot numbers listed: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
- Brand
Hologic- Category
Medical device
What to do — step by step
Check for Missing Instructions
Ensure you have the revised sterilization instructions for the Hologic Sizer Set. If missing, contact Hologic for guidance.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the product?
No, the recall does not require immediate discontinuation. However, you should check for the missing instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0669-2025 (October 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0669-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.