FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
Surgify Halo burr recalled for breakage risk
Surgify Medical's Halo 5.4 mm burr (Model 54.125.NVG.H1) may break during bi-portal endoscopic spinal surgery. The device has been distributed across multiple U.S. states. No injuries have been reported.
- If you use this burr in surgical procedures, contact Surgify Medical for guidance on the instruction update before using remaining inventory.
- Check your device lot number against UDI 06429811532106 to confirm if your stock is affected.
Hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Affected count
N/A
Manufactured in
Otakaari 5 I, N/A, Espoo, N/A, Finland
Products
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2570-2026More Surgify Medical recalls
- FDA-Device2026-07-01Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 40 mm spinal surgery burr recalled for breakage risk during endoscopic procedures
- FDA-Device2026-07-01Surgify Halo 4.0 mm surgical burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 3.0 mm surgical burr recalled for breakage risk during spinal surgery
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