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
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-2559-2026
- 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
- 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, 4.0 mm, Extendable, Model/Catalog Number: 40.000.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 CaliforniaFloridaIndianaLouisianaMassachusettsMinnesotaNew York
Questions about this recall
Why was it recalled?
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Which lots are affected?
UDI: 06429811532281; 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 98918This product is part of a recall event; the main page for the event is Surgify Halo, Medium recalled by Surgify Medical Oy.
More recalls from Surgify Medical OY
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Surgify Halo, Long recalled by Surgify Medical Oy | Surgify Medical OY | Device Malfunction | Nationwide |
| Device | CLASS II | Surgify Halo, Long recalled by Surgify Medical Oy | Surgify Medical OY | Device Malfunction | Nationwide |
| Device | CLASS II | Surgify Halo, Short recalled by Surgify Medical Oy | Surgify Medical OY | Device Malfunction | Nationwide |
| Device | CLASS II | Surgify Halo, Short recalled by Surgify Medical Oy | Surgify Medical OY | Device Malfunction | Nationwide |
| Device | CLASS II | Surgify Halo, Extendable recalled by Surgify Medical Oy | Surgify Medical OY | Device Malfunction | Nationwide |
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