# FDA recall Z-0363-2025

> **Karl Storz Endoscopy** · Class II · device recall initiated 2024-10-21.

## 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

- **Recall number:** Z-0363-2025
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0363-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0363-2025. Source: US FDA. Licensed CC0.

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