Olympus Corporation of the Americas is recalling 143 units of surgical equipment, including reusable silicone seals and Ellik Evacuator components, due to a discrepancy in cleaning instructions. The Japanese language package inserts contain sterilization directions that do not match the manufacturer's validated Instructions For Use (IFU). This recall affects multiple products including silicone seals used for endoscopes and Ellik Evacuator accessories like latex bulbs, glass bodies, and tubing.
If these medical devices are cleaned using the incorrect instructions provided in the Japanese inserts, they may not be properly sterilized. This poses a risk of cross-contamination or infection to patients during subsequent surgical or endoscopic procedures.
Reusable silicone seals fit over the biopsy port of endoscopes.
Reusable silicone seals fit over the biopsy port of endoscopes.
Compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
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.