The Recall Desk
HighFDA (Devices)·Z-2564-2026·Announced 2026-07-01

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.

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: 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
Category
Medical Device — Surgical Burrs / Drills
Hazard
  • burr-breakage
  • device-failure

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

Distributed nationwide across the United States.

Related recalls

Same category