FDAClass II · Medical device · Recalled July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2565-2026
Brand: SURGIFY MEDICAL OY
Classification: Class II
Units affected: 8 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

Affected products

Surgify Halo

Companies & origin

Recalling firm location: Espoo, N/A, Finland
Firm address: Otakaari 5 I, N/A, N/A

Identifying details (verbatim from the notice)

Product codes / lots: UDI: 06429811532311 ; All lots until the IFU update has been implemented
Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Firm notified the public via: E-Mail
FDA event ID: 98918
Recall initiated: April 30, 2026
FDA classified: June 24, 2026
FDA report date: July 1, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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