Surgify Halo surgical burrs recalled for potential breakage during spinal surgery
Surgify Medical OY is recalling Surgify Halo 5.4 mm Long surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The defect could affect patient safety during the 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: This is an FDA Class II recall of a surgical instrument with a potential for component breakage during a procedure, which poses a direct risk of harm to patients undergoing spinal surgery. The source text does not report any illnesses or injuries to date, but the hazard is concrete and the context is high-risk surgical intervention.
Plain-English summary
Surgify Medical OY is recalling Surgify Halo 5.4 mm Long surgical burrs (Model/Catalog Number 54.125.NVG.U1) due to potential for burr breakage occurring during bi-portal endoscopic spinal surgery (BESS).
The recall affects all lots of this product distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The product is identified by UDI 06429811532304.
Healthcare providers who have received this device should stop use and contact the manufacturer. Patients who have undergone procedures using this device should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.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: 06429811532304
- 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 recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- 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
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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