Klinika Medical recalls KliniTray Platte Faxitron GroB R sterile tissue resection margin examination boards (Model 2001155-F) due to potential microbial contamination. Affected units may pose infection risks during surgery.
Potential for microbial contamination.
Klinika Medical is recalling their KliniTray Platte Faxitron GroB R sterile tissue resection margin examination boards (Model 2001155-F) because they could become contaminated with microbes. This poses a risk of infection during surgical procedures if the device is used without proper sterilization.
The device is designed for precise surgical margin monitoring but may become contaminated with microbes if not properly sterilized. This contamination could lead to infections during surgery if the device is used without adequate cleaning.
Surgical teams and hospitals that use KliniTray Platte Faxitron GroB R sterile tissue resection margin examination boards (Model 2001155-F) are affected. Patients undergoing surgery with this device could be at risk of infection.
Check for the model number 2001155-F on the KliniTray Platte Faxitron GroB R sterile tissue resection margin examination board. The device was sold with lot number 25.023.01 and UDI-DI 4053185001177.
Look for the model number 2001155-F on the KliniTray Platte Faxitron GroB R sterile tissue resection margin examination board.
The recall states there is a potential for microbial contamination, so the device may not be safe to use without proper sterilization.
The recall does not specify a remedy, so the official notice does not provide instructions on what to do with the device.
Check for the model number 2001155-F and lot number 25.023.01 on the device.
We’ve drafted a message you can send Klinika Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1769-2025 — Klinika Medical Klinika Medical Hello, I own a Klinika Medical that is covered by recall Z-1769-2025 from Klinika Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
