FDA Device recall Z-1768-2025
KliniTray
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of KliniTray by Klinika Mdical Gmb, citing potential for microbial contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1768-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-04 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Klinika Mdical Gmb |
| Distribution | US |
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
Potential for microbial contamination.
Identifiers
| code_info | Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1768-2025%22
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