Z-1768-2025Class II

KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical...

Name: Z-1768-2025 KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical...
Creator: Klinika Mdical Gmb
Published: 2025-04-04
License: https://open.fda.gov/license/

Klinika Medical GmbH / initiated 2025-04-04 / Open, Classified / root cause: manufacturing process

FDA source

Klinika Mdical Gmb began a recall of KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise... on 2025-04-04. FDA classified it as Class II and gives the reason as "Potential for microbial contamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1768-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-04
Posted: 2025-05-15
Recalling firm: Klinika Medical GmbH
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.
Product code: FMH Container, Specimen, Sterile
Reason for recall: Potential for microbial contamination.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 620 units
Distribution: US Nationwide distribution in the state of Massachusetts.
Product codes and lots: Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1768-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1768-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-15
Z-1769-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-15

Product code FMH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)