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
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-2568-2026
- Classification
- Class II
- Recalled
- April 30, 2026
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