Surgify Halo surgical drill may break during spinal surgery procedures
Surgify Halo 4.0 mm surgical drills are being recalled because the burr may break during bi-portal endoscopic spinal surgery. The defect could interfere with the surgical procedure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical instrument with a documented risk of breakage during a critical procedure. No reported injuries or illnesses are stated in the source; however, the hazard poses a direct risk of harm during an invasive surgical procedure, placing it at the upper end of High severity.
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo 4.0 mm Short surgical drill (Model/Catalog Number 40.125.NVG.H1) due to a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS).
The recall affects all lots of this device until the Instructions for Use (IFU) have been updated. The device has been distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The UDI for the affected device is 06429811532083.
If you have this device in stock or in use, contact Surgify Medical OY to determine whether an updated IFU has been implemented. Do not use the device until you have confirmed the update has been applied.
The recalled product
- Product
- Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 06429811532083
- All lots until the IFU update has been implemented
Distribution
Part of a larger recall action
This product is one of 19 recalled by SURGIFY MEDICAL OY under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 19 products in this recall →Related recalls
Same manufacturer · SURGIFY MEDICAL OY
See all →- HighSurgify Halo Surgical Burr Recalled for Breakage Risk
FDA (Devices) · 2026-07-01
- HighSurgify Halo Spinal Surgery Burrs Recalled for Breakage Risk
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical drill recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical drill equipment recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burrs recalled for potential breakage
FDA (Devices) · 2026-07-01
Same hazard · burr breakage
See all →- HighSurgify Halo surgical burrs recalled for potential breakage during spinal surgery
FDA (Devices) · 2026-07-01
- HighSurgify Halo 4.0 mm Spinal Surgery Burrs May Break During Use
FDA (Devices) · 2026-07-01
- HighSurgify Halo spinal surgery burr tool potential breakage recall
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalling Potential Tool Breakage Risk
FDA (Devices) · 2026-07-01
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