The Recall Desk

FDA (Devices) recall action 96656

Klinika Mdical Gmb recalled 2 products on 2025-05-21

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-05-21
Critical
0
Units
780

Why these products were recalled

Potential for microbial contamination.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2025-05-21

    KliniTray surgical alignment system recalled for microbial contamination risk

    Klinika Medical is recalling the KliniTray tissue resection margin examination board (Model 2001105-F) due to potential microbial contamination. The device was distributed nationwide in Massachusetts.

    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 posi
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2025-05-21

    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.

    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
    Category
    Distribution
    1 state