# FDA recall Z-2558-2026

> **SURGIFY MEDICAL OY** · Class II · device recall initiated 2026-04-30.

## Product

Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2558-2026
- **Recalling firm:** SURGIFY MEDICAL OY
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-30
- **Report date:** 2026-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Espoo, N/A, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2558-2026

## Citation

> MORVS. FDA recall Z-2558-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-2558-2026. Source: US FDA. Licensed CC0.

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