Terragene S.A. is recalling approximately 36,937 sterilization indicator strips and process challenge devices, including the Terragene Integron and Bionova brands, because the instructions provided with the products do not match the FDA-cleared usage guidelines. This discrepancy could lead to medical tools being improperly sterilized if healthcare providers follow the incorrect instructions. These products were distributed to various medical facilities across eight U.S. states and are identified by specific lot numbers and UDI codes printed on the packaging.
If healthcare professionals rely on instructions that have not been cleared by the FDA, they may use incorrect sterilization parameters. This poses a risk that surgical instruments or medical devices may not be properly sterilized, potentially leading to patient infections or cross-contamination.
Information discrepancy update and contact manufacturer.
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.