FDA Medical devices recall ·
Surgify Halo, 4.0 mm, Extendable, Model recall
- Recall number
- Z-2558-2026
- Date
- (initiated April 30, 2026)
- Company / brand
- Surgify Medical Oy
Otakaari 5 I, Espoo, N/A, Finland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 112 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Why was it recalled?
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: California Florida Indiana Louisiana Massachusetts Minnesota New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2558-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.