FDAFDA recall Z-2570-2026 · Jul 1, 2026
SURGIFY MEDICAL OY: Surgify Halo recall
Recall found
Product
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Reason for recall
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI: 06429811532106 ; All lots until the IFU update has been implemented
- Quantity
- N/A
- Distribution
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
- Recalling firm
- SURGIFY MEDICAL OY, Espoo, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-04-30
Source: openFDA enforcement record Z-2570-2026 · search recall number Z-2570-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.