Hologic, Inc. is recalling 178 Sizer Set sterilization trays and sizer guides (Model F0101) because they were distributed with missing or outdated sterilization instructions. The set includes a sterilization tray and six individual sizers intended for use as surgical instrument guides. No injuries or incidents have been reported to date.
Using incorrect sterilization instructions may result in surgical instruments not being properly cleaned. This poses a risk of patient infection or other surgical complications if the equipment is used during a medical procedure.
Intended as a surgical instrument guide.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.