Surgify Halo surgical drill equipment recalled for potential burr breakage
Surgify Halo 3.0 mm Short surgical drills and burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially leaving fragments in the patient.
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 device recall involving risk of harm during surgical use (burr breakage during spinal surgery), and the source text does not report any illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 3.0 mm, Short (Model/Catalog Number 30.070.NVG.U2) surgical drilling and burr equipment. The device may experience burr breakage during bi-portal endoscopic spinal surgery (BESS).
The recalled equipment has been distributed nationwide to medical facilities in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The recall applies to all lots with UDI 06429811532205 until the Instructions for Use (IFU) have been updated.
Affected users, including surgeons and operating room staff, should stop using the affected lots immediately and contact Surgify Medical OY regarding replacement or updated product information. Healthcare providers should consult their equipment manuals and the manufacturer for guidance on safe use of this surgical equipment.
The recalled product
- Product
- Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; 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: 06429811532205
- 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
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- HighSurgify Halo surgical drill recalled for potential burr breakage
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