FDA recall Z-0363-2025

Karl Storz Endoscopy · Class II · device

Product

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.

Distribution

U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.

Key facts

Status
Ongoing
Initiation date
2024-10-21
Report date
2024-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0363-2025