Class II — SURGIFY MEDICAL OY
| Recalling firm | Surgify Medical Oy |
|---|---|
| Registered facility | SURGIFY MEDICAL OY (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| Product | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered) |
| Quantity | N/A |
| Distribution | US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL. |
| Initiated | 2026-04-30 |
| Classified | 2026-06-24 |
| Recall number | Z-2572-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SURGIFY MEDICAL OY (Z-2572-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98918/
Alerts for Surgify Medical Oy
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.