Quick Facts at a Glance
- Recall Date
- December 5, 2025
- Hazard Level
- HIGH
- Brand
- Beaver-Visitec International
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Beaver-Visitec International
- Product type
- Laser and Endoscopy System
- Model numbers
- OME6000U
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 5, 2025
Reported by FDA DEVICE
January 7, 2026
RecallRadar source check
January 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beaver-Visitec International, Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The BVI Leos Laser and Endoscopy System is used in medical settings for minimally invasive procedures. Healthcare providers purchase this equipment to enhance patient safety and treatment efficacy.
Why This Is Dangerous
The lack of ferrites on the USB cable can cause electrical interference, which may lead to device failure during use, posing a safety risk to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a very limited number of units, but it requires immediate action to ensure patient safety and compliance with medical standards.
Practical Guidance
How to identify if yours is affected
- Check the model number to verify if it is OME6000U.
- Locate the serial number on the device and verify against the recalled units list.
- Confirm the device was purchased within the specified distribution states.
Where to find product info
Serial numbers can typically be found on the back or bottom of the device and in the product documentation.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communication attempts with the company.
- Follow up via email or phone if no response is received within a week.
- Consider filing a complaint with the FDA if the issue persists.
How to prevent similar issues
- Always verify that medical devices meet safety standards before purchasing.
- Look for devices with clear certification markings such as UL or CPSC.
- Research product recalls before using any medical equipment.
Documentation advice
Keep copies of all correspondence with the manufacturer, including emails and phone call notes.
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Product Details
The recalled product is the BVI Leos Laser and Endoscopy System, Model Number OME6000U. It affects five units with serial numbers 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, and 77UBV500010. The product was distributed nationwide in Florida, Michigan, Oklahoma, Texas, and Wisconsin.
Key Facts
- Model Number: OME6000U
- Five units recalled
- Distributed in FL, MI, OK, TX, WI
- High electrical hazard risk
- Stop using immediately
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Safety Guide
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