Recall Z-2557-2026— SURGIFY MEDICAL OY

Name: FDA recall Z-2557-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Class II · Ongoing

Class II FDA medical device recall by SURGIFY MEDICAL OY, initiated 2026-04-30. It names one FDA 510(k) clearance: K253627. Product: Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered). Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS)..

Recalling firm: SURGIFY MEDICAL OY
Classification: Class II
Status: Ongoing
Initiated: 2026-04-30
Firm location: Espoo, N/A, Finland

510(k) clearances named in this recall

1 on FDA's record

K253627 — Surgify Halo (11 models)Surgify Medical OY·cleared 2026-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.