SURGIFY MEDICAL OY recalls Surgify Halo
- Recalling company
- SURGIFY MEDICAL OY
- Product
- Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- Reason
- Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 30, 2026
- Reported
- Jul 1, 2026
- Distribution
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
- Status
- Ongoing
- Quantity
- 0
- Lot / codes
- UDI: 06429811532274; All lots until the IFU update has been implemented
- Company location
- Espoo, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2563-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2563-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.