Karl Storz recalls irrigation tubing for Endomat Select UP210 models due to improper FDA labeling. This affects specific product numbers sold in the U.S. No immediate action needed as the hazard is labeling-related.
Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
Karl Storz is recalling irrigation tubing for their Endomat Select UP210 models because the product labels were not properly reviewed and approved by the FDA for U.S. distribution. This labeling issue means the tubing may not be legally used in the U.S. as intended, but it does not pose a direct safety risk to users.
The tubing was distributed in the U.S. without proper FDA labeling review. This means the product may not meet U.S. regulatory standards for intended use, but it does not cause physical harm or injury during normal use.
Owners of the Endomat Select UP210 irrigation tubing with product number 031523-10 are affected. Medical professionals using this specific tubing for endoscopy procedures are most at risk due to potential regulatory non-compliance.
Check for the product number 031523-10 on the tubing packaging or label. The tubing is part of the Endomat Select UP210 system and was sold with UDI-DI code 04048438006306.
Look for the product number 031523-10 on the tubing packaging or label to confirm if it is affected.
No, the hazard is labeling-related and does not cause physical harm. The tubing is safe to use but may not meet U.S. regulatory standards for intended use.
No immediate action is needed. The recall is for labeling compliance, not safety risks.
Check the product label for the number 031523-10. If it matches, you can continue using it but should contact Karl Storz for further guidance.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-0363-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-0363-2025 from Karl Storz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
