Surgify Halo — Class II medical device recall Z-2555-2026
Ongoing recall by SURGIFY MEDICAL OY, reported 2026-07-01, distributed nationwide. Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
| Recall number | Z-2555-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SURGIFY MEDICAL OY, Espoo, N/A, Finland |
| Recall initiated | 2026-04-30 |
| Classified | 2026-06-24 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 06429811532229 |
| Model numbers | 30.000.SEE.U2 |
Product
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Reason for recall
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2555-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.