MEDICAL DEVICE RECALLMODERATE

Surgify Halo Burr

Surgify Halo 3.0 mm burr recalled due to potential breakage during spinal surgery.

What to do

Stop using the affected Surgify Halo burr and accessories immediately. Contact Surgify Medical Oy for instructions on returning the product and obtaining a replacement.

Recalled

2026-04-30

Listed

2026-06-24

Updated

2026-09-08

Recall No.

Z-2568-2026

Agency

FDA

Firm

SURGIFY MEDICAL OY

Recall ID

98918

Status

ONGOING

Why it was recalled

Surgify Medical Oy is recalling the Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number 30.000.SEE.U2, along with drills, burrs, trephines, and accessories, due to a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS). Burr breakage could cause serious injury to the patient.

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.

Lot code: All lots until the IFU update has been implemented

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

Show all 19 products

Product	Recall #	UDI-DI
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)	Z-2557-2026	06429811532212
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)	Z-2570-2026	06429811532106
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)	Z-2564-2026	06429830116998
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)	Z-2556-2026	06429811532205
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)	Z-2569-2026	06429811532328
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)	Z-2555-2026	06429811532229
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)	Z-2573-2026	06429811532335
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)	Z-2560-2026	–
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)	Z-2567-2026	06429811532298
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)	Z-2563-2026	06429811532274
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)	Z-2571-2026	06429811532304

Where it was sold

Distributed nationwide.

Timeline

2026-04-30Firm initiated recall
2026-06-24Publicly announced
2026-06-25Listed on Recall Canary
2026-09-08Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification