FDA Medical devices recall ·
BVI Leos Laser and Endoscopy System recall
- Recall number
- Z-1008-2026
- Date
- (initiated December 5, 2025)
- Company / brand
- Beaver-Visitec International, Inc.
500 Totten Pond Rd, Waltham, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Why was it 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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Distribution
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
States: Florida Michigan Oklahoma Texas Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1008-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.