Unetixs Vascular, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1194-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

Product Classification:

Class II

Date Initiated: February 10, 2023

Date Posted: March 8, 2023

Recall Number: Z-1194-2023

Event ID: 91564

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 2310 units

Code Information:

All Serial Numbers

Distribution Pattern:

Worldwide distribution - US Nationwide and Global distribution.

Voluntary or Mandated:

Voluntary: Firm initiated