Beaver-Visitec International, Inc. recalls BVI Leos Laser and Endoscopy System.
- Recalling company
- Beaver-Visitec International, Inc.
- Product
- BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
- Reason
- 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).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 5, 2025
- Reported
- Jan 7, 2026
- Distribution
- US Nationwide distribution in the states of FL, MI, OK, TX, WI.
- Status
- Ongoing
- Quantity
- 5 units
- Lot / codes
- Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
- Company location
- Waltham, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1008-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1008-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.