Beaver-Visitec International, Inc.: Medical Device Recall in 2026 - (Recall #: Z-1008-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 5, 2025

Date Posted: January 7, 2026

Recall Number: Z-1008-2026

Event ID: 98076

Reason for Recall:

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).

Status: Ongoing

Product Quantity: 5 units

Code Information:

Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated