# FDA recall Z-1768-2025

> **Klinika Mdical Gmb** · Class II · device recall initiated 2025-04-04.

## Product

KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F    The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.

## Reason for recall

Potential for microbial contamination.

## Distribution

US Nationwide distribution in the state of Massachusetts.

## Key facts

- **Recall number:** Z-1768-2025
- **Recalling firm:** Klinika Mdical Gmb
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-04
- **Report date:** 2025-05-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2025

## Citation

> AI Analytics. FDA recall Z-1768-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1768-2025. Source: US FDA. Licensed CC0.

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