Medline Industries is recalling 355 units of various reprocessed Covidien LigaSure and Ethicon Harmonic surgical instruments because the packaging trays may have an incomplete seal. These devices, which include various sealer/divider models and shears used in electrosurgical procedures, were distributed across the United States. If the packaging seal is compromised, the sterile barrier of the medical device may be broken, leading to a risk of contamination and serious infection during surgery.
An incomplete seal on the packaging tray can allow pathogens to enter the sterile container, potentially exposing patients to non-sterile instruments during surgical procedures. This poses a risk of post-operative infections or surgical site contamination.
Product quarantine and potential replacement
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 ยท 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.