Surgify Halo Surgical Burr Recalling Potential Tool Breakage Risk
SURGIFY MEDICAL OY is recalling the Surgify Halo 5.4 mm Extendable surgical burr due to risk of burr breakage during bi-portal endoscopic spinal surgery (BESS). The recalled units are distributed nationwide.
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 for a surgical device with potential for breakage during use, which poses a risk of harm (tool fragment retention in surgical field) in a high-risk procedure. No injuries or illnesses are reported in the source text, but the hazard is directly stated and applies to active surgical use.
Plain-English summary
SURGIFY MEDICAL OY is recalling the Surgify Halo, 5.4 mm, Extendable (Model/Catalog Number: 54.000.SEE.U1), a powered surgical drilling and cutting tool used in spine surgery. The recall has been issued because the burr component has the potential to break during bi-portal endoscopic spinal surgery (BESS) procedures.
The recalled product, with UDI 06429811532311, has been distributed nationwide across the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. All lots are affected until the Instructions for Use (IFU) have been updated.
If you have received or used this product, contact SURGIFY MEDICAL OY immediately for instructions on how to proceed. Do not use the product until further notice.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Affected units
- 8
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: 06429811532311
- 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
FDA (Devices) · 2026-07-01
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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