Surgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
Surgify Medical is recalling Surgify Halo 4.0 mm Extendable surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The breakage could create a safety hazard 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall involving a surgical instrument used in spinal procedures. The potential for device breakage during surgery creates a risk of intraoperative complications and patient harm, meeting the Severe criteria for a Class II recall with risk of harm during an invasive procedure.
Plain-English summary
Surgify Medical OY is recalling Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number 40.000.SEE.H1 surgical burrs. The device may break during bi-portal endoscopic spinal surgery (BESS), which could create an unexpected hazard during the procedure.
This recall affects 112 units distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The affected devices are identified by UDI 06429811532076 and include all lots until the Instructions for Use (IFU) update has been implemented.
Healthcare facilities and surgical centers that use this device should stop using affected units immediately and contact Surgify Medical OY for further guidance. Surgeons and surgical teams should verify they are not using recalled units before performing bi-portal endoscopic spinal surgery procedures.
The recalled product
- Product
- Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Affected units
- 112
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: 06429811532076
- 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
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FDA (Devices) · 2026-07-01
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- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
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