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Medium risk Drugs & MedicationsClass II

SURGIFY MEDICAL OY Recall

Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

Updated April 30, 2026

SURGIFY MEDICAL OY is recalling Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered). Hazard: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

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, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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

Brands affected

SURGIFY MEDICAL OY
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-2565-2026
Classification
Class II
Recalled
April 30, 2026
Read the official notice

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