Class II — Unetixs Vascular, Inc.
| Recalling firm | UNETIXS VASCULAR, INC. |
|---|---|
| Registered facility | UNETIXS VASCULAR, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. |
| Product | MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01 |
| Quantity | 2000 units |
| Distribution | Worldwide distribution - US Nationwide and Global distribution. |
| Initiated | 2023-02-10 |
| Classified | 2023-03-01 |
| Recall number | Z-1195-2023 |
| 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 — Unetixs Vascular, Inc. (Z-1195-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91564/
Alerts for UNETIXS VASCULAR, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.