Karl Storz Endoscopy is recalling 40 units of Irrigation Tubing used with the Endomat Select UP210 (REF 031523-10). The recall was initiated because the product's label includes an intended use that has not been reviewed or approved by the FDA for distribution in the United States. There have been no reported incidents or injuries associated with this issue, but the tubing was distributed to facilities in 13 states including Texas, New York, and Ohio.
The product label contains medical claims that have not been verified for safety or effectiveness by the FDA. Using a medical device for an unapproved purpose could lead to unexpected clinical outcomes or improper use of surgical equipment.
Recall number: Z-0363-2025
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.