Lower riskMedical device recall · FDA · Published December 5, 2025
Beaver-Visitec OME6000U Laser System Recall: USB Cable Manufacturing Issue
Beaver-Visitec recalls OME6000U laser systems due to missing ferrites in USB cables, risking communication failure. Affected units have specific serial numbers and model numbers.
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).
“Beaver-Visitec OME6000U Laser System Recall: USB Cable Manufacturing Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50518-beaver-visitec-ome6000u-laser-system-recall-usb-cable-manufacturing-issue. Based on FDA recall #Z-1008-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1008-2026%22&limit=1).
The FDA announced on Dec. 5, 2025, that Beaver-Visitec International, Inc. is recalling the BVI Leos Laser and Endoscopy System due to a manufacturing deviation in the USB cable assembly. The company initiated this voluntary Class II recall affecting five units distributed nationwide.
How to tell if you have it
Brand: Beaver-Visitec
Product: BVI Leos Laser and Endoscopy System
Model Number: OME6000U
UPC: 00886158037576
Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010
The hazard
The recall cites a manufacturing deviation where the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. This omission results in non-conformance to design specifications requiring two ferrites at each end of the cable.
Context
GovInfoNow's records show Beaver-Visitec International, Inc. has 15 other recalls on record since Nov. 3, 2017. Other recent recalls of similar products include Beaver Visitec CustomEyes Procedure Packs Recall (July 26, 2024), Xstar Safety Slit Knife Recall (May 10, 2024), and Beaver Visitec Irrigation Handle Recall (Feb. 2, 2024). Other recent recalls of similar products include Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall (March 25, 2026) and Terex Power Over Fiber Base Module Recall (May 11, 2026).
How to tell if you have this one
Check for the model number OME6000U on the device. Affected units have serial numbers starting with 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, or 77UBV500010.
Brand
Beaver-Visitec
Product
BVI Leos Laser and Endoscopy System. Model Number: OME6000U
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Verify the model number is OME6000U on the device label.
Contact Manufacturer
Reach out to Beaver-Visitec for specific guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, MI, OK, TX, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Michigan, Oklahoma, Texas, Wisconsin.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1008-2026 (December 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1008-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.