Beaver-Visitec International, Inc. recalls BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Recall date

December 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1008-2026

FDA classification

Class II

Brand / firm

Beaver-Visitec International, Inc.

Sold / distributed

US Nationwide distribution in the states of FL, MI, OK, TX, WI.

Why it was recalled

Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.