KliniTray Platte Faxitron Sterile Tissue Resection Examination Board Recalled
KliniTray Platte Faxitron sterile tissue resection margin examination boards (Model 2001155-F) are being recalled due to potential for microbial contamination. Affected units were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device with potential for microbial contamination, a high-risk pathogen scenario. The source text does not report any illnesses or injuries to date, but the hazard type (contamination) and device classification meet the High (score 3) threshold under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Klinika Medical GmbH is recalling the KliniTray Platte Faxitron sterile tissue resection margin examination board (Model Number 2001155-F, large). The device is a system used during surgical procedures for precise monitoring, recording, and visualization of alignment to ensure correct orientation and positioning of tissue to be removed.
The recall is due to a potential for microbial contamination. The affected units include Lot Number 25.023.01, with 160 units distributed nationwide in the state of Massachusetts.
Patients and healthcare providers who have received this device should contact Klinika Medical GmbH or the FDA for information on how to proceed. Healthcare facilities should cease use of affected units and follow instructions from the manufacturer regarding returns or replacement devices.
The recalled product
- Product
- KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact
- Manufacturer
- Klinika Mdical Gmb
- Hazard
- microbial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 2001155-F. UDI-DI: 4053185001177. Lot Number: 25.023.01
Distribution
Distributed nationwide across the United States.
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