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Hologic, Inc 2024-12-18 Health serious FDA
Health · FDA · Recall #FDA-Z-0669-2025

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical… Recall

Issued December 18, 2024 · Hologic, Inc

In December 2024, Hologic, Inc recalled the Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set

What you should do

  1. 1 Stop using Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Hologic, Inc to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Hologic, Inc
Category
Health
Recall date
December 18, 2024
Units affected
Not reported
Sold at
US Nationwide distribution.
Recall number
FDA-Z-0669-2025
Made in
United States
Issuing agency
FDA

In context

  • Hologic, Inc has 4 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 737th Health recall we've logged in 2024.
Read the official FDA notice

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