Surgify Halo surgical burrs recalled for potential breakage risk
Surgify Medical is recalling the Surgify Halo 5.4 mm surgical burrs due to potential breakage during spinal surgery procedures.
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 involving a surgical device with risk of harm (burr breakage during critical spinal procedures). Although no reported injuries or illnesses are stated in the source text, the hazard is substantial and directly applicable to active surgical procedures, meeting the High threshold for risk-of-harm products.
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 5.4 mm, Long (Model/Catalog Number 54.125.NVG.H1) surgical drills, burrs, trephines, and accessories. The recall is due to potential for burr breakage occurring during bi-portal endoscopic spinal surgery (BESS).
The affected product has been distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The recall affects all lots until the IFU (Instructions for Use) update has been implemented. The product UDI is 06429811532106.
Healthcare facilities and surgeons using this device should stop use and contact Surgify Medical OY for updated instructions and product replacement options. Patients who have undergone procedures using this device should consult their healthcare provider if they have any concerns.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.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: 06429811532106
- 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
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 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
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