KliniTray Tissue Margin Examination Boards Recalled for Microbial Contamination

Agency Publication Date: May 15, 2025

Summary

Klinika Mdical Gmb is recalling 780 units of its KliniTray and KliniTray Platte Faxitron tissue margin examination boards due to potential microbial contamination. These medical devices are used during surgical procedures to precisely position, monitor, and record tissue margins removed from patients. While no injuries or infections have been reported to date, the manufacturer is voluntarily recalling these boards to ensure patient safety.

Risk

Microbial contamination on equipment used in surgical settings can lead to serious post-operative infections for patients. The contamination compromises the sterility required for surgical tools used to handle patient tissue.

What You Should Do

This recall involves KliniTray and KliniTray Platte Faxitron sterile tissue resection margin examination boards, including model numbers 2001105-F and 2001155-F.
Check the product label for Lot Number 25.019.01 (small board) or Lot Number 25.023.01 (large board) and UDI-DI 4053185001177 to confirm if your inventory is affected.
Stop using the recalled devices immediately to prevent potential patient exposure to contaminants.
Contact Klinika Mdical Gmb or your specialty medical distributor to arrange for the return, replacement, or correction of the affected boards.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have further questions regarding this safety alert.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: KliniTray Tissue resection margin examination board/small

Variants: Small

Model / REF:

2001105-F

Lot Numbers:

25.019.01

UDI:

4053185001177

Recall Number: Z-1768-2025

Product: KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large

Variants: Large

Model / REF:

2001155-F

Lot Numbers:

25.023.01

UDI:

4053185001177

Recall Number: Z-1769-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96656

Status: Active

Manufacturer: Klinika Mdical Gmb

Sold By: Specialty medical distributors

Manufactured In: Germany

Units Affected: 2 products (620 units; 160 units)

Distributed To: Massachusetts

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves KliniTray and KliniTray Platte Faxitron sterile tissue resection margin examination boards, including model numbers 2001105-F and 2001155-F.

Check the product label for Lot Number 25.019.01 (small board) or Lot Number 25.023.01 (large board) and UDI-DI 4053185001177 to confirm if your inventory is affected.

Stop using the recalled devices immediately to prevent potential patient exposure to contaminants.

Contact Klinika Mdical Gmb or your specialty medical distributor to arrange for the return, replacement, or correction of the affected boards.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have further questions regarding this safety alert.

Affected Products

Product: KliniTray Tissue resection margin examination board/small

Variants: Small

Model / REF:

2001105-F

Lot Numbers:

25.019.01

UDI:

4053185001177

Recall Number: Z-1768-2025

Product: KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large

Variants: Large

Model / REF:

2001155-F

Lot Numbers:

25.023.01

UDI:

4053185001177

Recall Number: Z-1769-2025