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very recent recall may be missing. Everything shown is accurate as of the last checked time on this page —
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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-2563-2026
- Brand
- SURGIFY MEDICAL OY
- Classification
- Class II
- Units affected
- 0
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Affected products
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: 06429811532274; 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 23, 2026 at 11:04 PM UTC.
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