SurgiSmoke Solutions is recalling 2,505 Flamingo Funnel medical devices because they were manufactured with a drape that is not compatible with the gamma sterilization process used. The recall affects Small, Medium, and Large models distributed worldwide and across 13 U.S. states. No injuries or incidents have been reported to date, and the company is contacting affected customers by letter.
The use of a non-compatible drape during the sterilization process may result in the device not being properly sterile, which could lead to surgical site infections or other patient complications during medical procedures.
Associated with manufacturing nonconformance involving non-gamma sterilization compatible drape.
Associated with manufacturing nonconformance involving non-gamma sterilization compatible drape.
Associated with manufacturing nonconformance involving non-gamma sterilization compatible drape.
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
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