Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Nu
Summary
The FDA issued a Class II for Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Sur by Hologic, Inc. Reason: IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set.
Details
Source
Device Recall
External ID
Z-0669-2025
Action Date
2024-12-18
Status
Completed
Category
device
Product Description
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Lot/Code Info: Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
Quantity Affected: 178 units
Reason for Recall
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-10
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hologic, Inc has 41 FDA actions in our database, including 22 recalls and 19 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hologic, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hologic, Inc have FDA actions?
Hologic, Inc has 41 FDA actions in our database, including 22 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0669-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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