KliniTray — Class II medical device recall Z-1768-2025
Ongoing recall by Klinika Mdical Gmb, reported 2025-05-21, distributed nationwide. Potential for microbial contamination.
| Recall number | Z-1768-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Klinika Mdical Gmb, Usingen, Germany |
| Recall initiated | 2025-04-04 |
| Classified | 2025-05-15 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 620 units |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 04053185001177 |
| Lot numbers | 25.019.01 |
| Model numbers | 2001105-F |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1768-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.