Class II

Medical Device Recall: Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY · April 30, 2026

Reason for Recall

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Distribution

US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.

States Affected

NATIONWIDE

Quantity Affected

112 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2558-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.