Reported Dec 18, 2024 · Completed

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog…

Hologic, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020

Is this the product you have?

  • Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical
  • instrument guide Model/Catalog NumberF0101
Lot codes and dates
  • Model No F0101. UDI 15420045515390
  • Lot Numbers
    • 186728
    • SS1-200727
    • SS1-181121
    • SS1-190301
    • SS1-190501
    • 175517
    • 175516
    • 162427
    • 140718-01
    • 171056
    • 175515
Amount recalled
178 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.