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.
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
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.
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.
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.
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.
Ensure you have the revised sterilization instructions for the Hologic Sizer Set. If missing, contact Hologic for guidance.
No, the recall does not require immediate discontinuation. However, you should check for the missing instructions.
Model number F0101 with lot numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
Hologic will provide revised sterilization instructions if you contact them directly.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-0669-2025 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-0669-2025 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
