Surgify Halo Surgical Burrs Recalled Due to Breakage Risk
SURGIFY MEDICAL OY is recalling Surgify Halo 5.4 mm Extendable surgical burrs (Model 54.000.SEE.H1) due to potential for burr breakage during bi-portal endoscopic spinal surgery. The device has been 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: FDA Class II recall for a surgical device with potential for breakage during a procedure poses a risk of harm to patients, even though no illnesses or injuries are reported in the source text. This falls under the High category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
SURGIFY MEDICAL OY is recalling the Surgify Halo, 5.4 mm, Extendable surgical burr (Model/Catalog Number: 54.000.SEE.H1) distributed nationwide in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida.
The recall was initiated because of a potential for burr breakage occurring during bi-portal endoscopic spinal surgery (BESS). A total of 53 units have been distributed. The affected product is identified by UDI 06429830116998, and all lots are affected until the instructions for use (IFU) have been updated.
Healthcare providers and facilities that have received this device should stop use and contact SURGIFY MEDICAL OY for instructions on how to proceed. Patients who have undergone procedures using this device should consult with their healthcare provider if they have any concerns.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Affected units
- 53
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: 06429830116998
- 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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