The FDA has posted 5 enforcement recalls of implantable radiographic marker devices since 2025, none of them Class I (most serious). Most recent report: Jun 3, 2026.
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Potential for contamination with cotton fibers.
Potential for contamination with cotton fibers.
There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Marker, Radiographic, Implantable”). Informational only — verify against the FDA before acting.