# FDA recall Z-0716-2025

> **Trokamed GmbH** · Class I · device recall initiated 2024-11-27.

## Product

Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.

## Reason for recall

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

## Distribution

US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .

## Key facts

- **Recall number:** Z-0716-2025
- **Recalling firm:** Trokamed GmbH
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-27
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Geisingen, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0716-2025

## Citation

> AI Analytics. FDA recall Z-0716-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0716-2025. Source: US FDA. Licensed CC0.

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