CLASS II ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report

Surgify Halo, Extendable recalled by Surgify Medical Oy

Surgify Medical Oy is recalling Surgify Halo, Extendable, distributed nationwide in the US. The recall was initiated on 30 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 06429811532311 ; All lots until the IFU update has been implemented

Quantity recalled8 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2565-2026
FDA event ID: 98918
Recalling firm: Surgify Medical Oy, Espoo, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 30 Apr 2026
FDA classified: 24 Jun 2026
Reported: 1 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

30 Apr 2026	Recall initiated by company
24 Jun 2026	Classified by FDA	+55 days
1 Jul 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.

Nationwide California Florida Indiana Louisiana Massachusetts Minnesota New York

Questions about this recall

Is Surgify Halo, Extendable recalled?

Yes. Surgify Medical Oy recalled Surgify Halo, Extendable on 30 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2565-2026.

Why was it recalled?

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

Which lots are affected?

UDI: 06429811532311 ; All lots until the IFU update has been implemented

Where was it sold?

US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Surgify Medical Oy

All 19

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	Surgify Halo, Long recalled by Surgify Medical Oy	Surgify Medical Oy	Device Malfunction	Nationwide
1 Jul 2026Device	CLASS II	Surgify Halo, Long recalled by Surgify Medical Oy	Surgify Medical Oy	Device Malfunction	Nationwide
1 Jul 2026Device	CLASS II	Surgify Halo, Short recalled by Surgify Medical Oy	Surgify Medical Oy	Device Malfunction	Nationwide
1 Jul 2026Device	CLASS II	Surgify Halo, Short recalled by Surgify Medical Oy	Surgify Medical Oy	Device Malfunction	Nationwide
1 Jul 2026Device	CLASS II	Surgify Halo, Extendable recalled by Surgify Medical Oy	Surgify Medical Oy	Device Malfunction	Nationwide

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