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.
What this means for you
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
- Hazard
- burr-breakage
- surgical-complication
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
Distributed nationwide across the United States.
Related recalls
Same category
- HighIntera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall
FDA (Devices) · 2026-07-01
- ModerateThuvera Laser Console Software Version 2.2 Recall Notice
FDA (Devices) · 2026-07-01
- HighSurgify Halo Spinal Surgery Burrs Recalled for Breakage Risk
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01