Surgify Halo surgical burrs recalled for potential breakage
Surgify Halo 5.4 mm Short surgical burrs may break during bi-portal endoscopic spinal surgery. FDA Class II recall affects multiple U.S. 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 instrument with a risk-of-harm hazard (burr breakage during spinal surgery). No reported injuries or hospitalizations are mentioned in the source text, placing it at the high end of High per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Surgify Medical OY is recalling Surgify Halo 5.4 mm Short burrs, Model/Catalog Number 54.070.NVG.U1, due to potential for burr breakage during bi-portal endoscopic spinal surgery (BESS). The recalled product is identified by UDI 06429811532298 and includes all lots until the Instructions for Use (IFU) update has been implemented.
The recalled surgical burrs have been distributed nationwide in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. This is an FDA Class II recall.
Surgeons and surgical facilities using this product should immediately discontinue use until the IFU update has been implemented. Facilities should review procedures with affected patients and consult the FDA guidance on this recall for additional instructions.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; 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: 06429811532298
- 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
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- HighSurgify Halo Spinal Surgery Burrs Recalled for Breakage Risk
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- HighSurgify Halo surgical drill recalled for potential burr breakage
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- HighSurgify Halo surgical drill equipment recalled for potential burr breakage
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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
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- 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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