KliniTray Tissue Margin Board (Klinika Medical) – Microbial Contamination (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany
Lot Codes / Batch Numbers
Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01
Products Sold
Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01
Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany is recalling KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The due to Potential for microbial contamination.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for microbial contamination.
Recommended Action
Per FDA guidance
Single distributor was notified via email on 04/04/2025 with an "URGENT FIELD SAFETY NOTICE - PRODUCT RECALL" letter. The letter instructed the distributor to Identify and quarantine all units of the affected LOT numbers, do not distribute or use these products, treat the products as non-sterile (clean packed) and ensure they are not used on the sterile field, and inform all relevant departments or customers within your distribution chain about this FSCA. Additionally, the distributor was requested to complete and return the acknowledgment form by 04/16/2025, even if you no longer have affected stock.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026