FDAClass IIMay 21, 2025

KliniTray. KlinioTray. Tissue resection margin recall: Contamination

KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the…

Why was KliniTray. KlinioTray. Tissue resection margin recalled?

Potential for microbial contamination.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01

Product
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the…
Recalling firm
Klinika Mdical Gmb
Quantity
620 units
Distribution
US Nationwide distribution in the state of Massachusetts.
Recall date
May 21, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls