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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96656

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 04, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Klinika Mdical Gmb

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-1768-2025
Recall number
Z-1768-2025
Initiated
April 04, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Klinika Mdical Gmb
Quantity
620 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for microbial contamination.

Code information

Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01

Distribution pattern

US Nationwide distribution in the state of Massachusetts.

device · product 2 of 2

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 orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.

Z-1769-2025
Recall number
Z-1769-2025
Initiated
April 04, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Klinika Mdical Gmb
Quantity
160 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for microbial contamination.

Code information

Model Number: 2001155-F. UDI-DI: 4053185001177. Lot Number: 25.023.01

Distribution pattern

US Nationwide distribution in the state of Massachusetts.