Hologic Sizer Set Missing Instructions for Use and Sterilization
Hologic is recalling 178 units of Sizer Set surgical instruments nationwide because instructions for use and revised sterilization instructions were not provided with the product.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recall due to missing critical documentation (instructions for use and sterilization instructions). No reported injuries or illnesses have been documented. Missing instructions without reported harm aligns with Moderate severity for documentation issues.
Plain-English summary
Hologic, Inc. is recalling 178 units of the Hologic Sizer Set (Model F0101), a surgical instrument guide. The recall was issued because the instructions for use (IFU) and revised sterilization instructions were not provided with the Sizer Set sterilization tray.
The recalled units were distributed nationwide in the United States. Units can be identified by Model No. F0101 and the following lot numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, and 175515.
Healthcare facilities and medical professionals who received this product should immediately stop using it until the proper instructions for use and sterilization instructions are obtained from Hologic. Contact Hologic for corrected instructions and guidance on proper use and sterilization of the device.
The recalled product
- Product
- Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
- Manufacturer
- Hologic, Inc
- Affected units
- 178
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Model No F0101. UDI 15420045515390. Lot Numbers: 186728
- SS1-200727
- SS1-181121
- SS1-190301
- SS1-190501
- 175517
- 175516
- 162427
- 140718-01
- 171056
- 175515.
Distribution
Distributed nationwide across the United States.
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