Surgify Halo surgical drill recalled for potential burr breakage
Surgify Halo 3.0 mm surgical drills may experience burr breakage during bi-portal endoscopic spinal surgery. The FDA is requesting the recall of this device across multiple US states.
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: This is an FDA Class II recall of a surgical device with a risk-of-harm hazard (burr breakage during spinal surgery) where no reported injuries are stated in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 3.0 mm, Long (Model/Catalog Number: 30.125.NVG.U2) due to a potential for burr breakage that may occur during bi-portal endoscopic spinal surgery (BESS).
The recalled drills, burrs, trephines, and accessories are simple, powered surgical instruments. All lots are affected until the Instruction For Use (IFU) update has been implemented. The device is identified by UDI: 06429811532212.
The product has been distributed nationwide in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. Healthcare facilities and surgical centers in these areas that possess this device should contact the manufacturer or consult the FDA recall notice for instructions on how to proceed.
The recalled product
- Product
- Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; 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: 06429811532212
- 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 drill may break during spinal surgery procedures
FDA (Devices) · 2026-07-01
- 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 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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