FDAMarch 14, 2025device
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
What to do
FDA enforcement status: Ongoing
Brands named
pro med instrumentspropro med
UPCs
04250435506738
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAdvance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-282026-05-27
- FDAeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-1562026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
- FDAeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-1572026-03-02
- FDAeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-1512026-03-02
- FDAeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-1582026-03-02
- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-1592026-03-02
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