Class II — Vortex Surgical Inc.
| Recalling firm | Vortex Surgical, Inc. |
|---|---|
| Registered facility | Vortex Surgical, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly. |
| Product | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; |
| Quantity | 221 units |
| Distribution | US and Japan |
| Initiated | 2025-11-19 |
| Classified | 2025-12-30 |
| Recall number | Z-1004-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vortex Surgical Inc. (Z-1004-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98032/
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