FDAClass II · Medical device · Recall Z-2558-2026 · Recalled July 1, 2026

Surgify Halo recall — SURGIFY MEDICAL OY

Agency report date: July 1, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Surgify Halo
Company / brand: SURGIFY MEDICAL OY
Lot / serial / date codes: UDI: 06429811532076; All lots until the IFU update has been implemented
Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Surgify Halo recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2558-2026
Brand: All SURGIFY MEDICAL OY recalls
Classification: Class II
Units affected: 112 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Surgify Halo recall status

Companies & origin

Recalling firm location: Espoo, N/A, Finland
Firm address: Otakaari 5 I, N/A, N/A

Identifying details (verbatim from the notice)

Product codes / lots: UDI: 06429811532076; All lots until the IFU update has been implemented
Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Firm notified the public via: E-Mail
FDA event ID: 98918
Recall initiated: April 30, 2026
FDA classified: June 24, 2026
FDA report date: July 1, 2026

Other medical device recalls from around the same time

Hillrom VOLARA System P recall — Baxter Healthcare CorporationFDA · July 8, 2026
Breathing circuit set recall — Hamilton Medical AGFDA · July 8, 2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.FDA · July 1, 2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.FDA · July 1, 2026
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.FDA · July 1, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 29, 2026 at 6:00 PM UTC.

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