CLASS II ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report
KliniTray. KlinioTray. Tissue resection margin examination recalled
Klinika Mdical Gmb is recalling KliniTray. KlinioTray. Tissue resection margin examination board/small, distributed nationwide in the US. The recall was initiated on 4 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1768-2025
- FDA event ID
- 96656
- Recalling firm
- Klinika Mdical Gmb, Usingen
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Apr 2025
- FDA classified
- 15 May 2025
- Reported
- 21 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 4 Apr 2025 | Recall initiated by company | |
| 15 May 2025 | Classified by FDA | +41 days |
| 21 May 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for microbial contamination.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the state of Massachusetts.
Questions about this recall
Why was it recalled?
Potential for microbial contamination.
Which lots are affected?
Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01
Where was it sold?
US Nationwide distribution in the state of Massachusetts.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96656This product is part of a recall event; the main page for the event is KliniTray Platte Faxitron ,groB "R" sterile recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | KliniTray Platte Faxitron ,groB "R" sterile recalled | Klinika Mdical Gmb | Sterility | Nationwide |
More recalls from Klinika Mdical Gmb
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | KliniTray Platte Faxitron ,groB "R" sterile recalled | Klinika Mdical Gmb | Sterility | Nationwide |
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| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |