Recall Z-0363-2025— Karl Storz Endoscopy

Name: FDA recall Z-0363-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-21

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2024-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC. Reason: 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..

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Ongoing
Initiated: 2024-10-21
Firm location: El Segundo, CA, United States

Product description

Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.