Surgify Halo recall (SURGIFY MEDICAL OY)
Medical deviceClass IIOngoing
Summary: SURGIFY MEDICAL OY is recalling Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered). Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
What is being recalled
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Why
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL. (states named: California, Florida, Indiana, Louisiana, Massachusetts, Minnesota, New York)
How to tell if yours is affected
UDI: 06429811532205; All lots until the IFU update has been implemented
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2556-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 30, 2026 |
| Reported | July 1, 2026 |
| Company | SURGIFY MEDICAL OY |
| Company location | Espoo, N/A, Finland |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
More recalls from SURGIFY MEDICAL OY · all medical device recalls · recalls from April 2026