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Surgify Halo Drill Burr
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MEDICAL DEVICE RECALLMODERATE

Surgify Halo Drill Burr

Surgify Halo drill burr recalled over breakage risk during spinal surgery.

What to do

Stop using the affected Surgify Halo drill burrs immediately. Contact Surgify Medical for instructions on returning the product and obtaining a replacement.

Posted
Updated
Recall No.
Z-2558-2026
Agency
Firm
SURGIFY MEDICAL OY
Recall ID
98918
Status
ONGOING

Why it was recalled

Surgify Medical is recalling the Surgify Halo drill burr due to a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS). The affected models include the 5.4 mm Long (54.125.NVG.U1) and the 3.0 mm Extendable (30.000.SEE.U2).

Is mine affected?

This recall covers 19 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductUPCRecall #
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)06429811532120Z-2568-2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)06429811532076Z-2558-2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)06429811532267Z-2561-2026
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)06429811532137Z-2572-2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)06429811532083Z-2562-2026
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)06429811532311Z-2565-2026
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)06429811532090Z-2566-2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)06429811532281Z-2559-2026

+11 more affected products. See the full list at the official source below.

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification