# FDA recall Z-2794-2026

> **Karl Storz Endoscopy** · Class II · device recall initiated 2026-05-21.

## Product

Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.

## Reason for recall

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

## Distribution

US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.

## Key facts

- **Recall number:** Z-2794-2026
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-21
- **Report date:** 2026-07-29

- **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-2794-2026

## Citation

> AI Analytics. FDA recall Z-2794-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2794-2026. Source: US FDA. Licensed CC0.

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