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Medium risk Medical DevicesClass II

Surgify Halo Surgical Burr Recall

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)

Updated April 30, 2026

Surgify Halo 5.4 mm Medium burr drills (Model 54.085.SHD.H1) used in spinal surgery can break during the procedure. A broken burr could complicate surgery or cause injury.

Is the SURGIFY MEDICAL OY recalled? Yes. This product was recalled by FDA on April 30, 2026. Details below.

What is recalled

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number 54.085.SHD.H1; burrs, trephines and accessories (simple, powered).

Am I affected

You are affected if you are a hospital, surgical center, or surgeon who uses or has in stock the Surgify Halo Model 54.085.SHD.H1 burr system for bi-portal endoscopic spinal surgery.

What to do right now

Stop using this burr system immediately. Contact Surgify Medical OY or your distributor for instructions on return, replacement, or proper disposal. Do not use affected units in any surgical procedures.

The hazard

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Brands affected

SURGIFY MEDICAL OY
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2568-2026
Classification
Class II
Recalled
April 30, 2026
Read the official notice

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