CLASS II ONGOING Device recall · Reported 7 Jan 2026 · FDA Enforcement Report
BVI Leos Laser and Endoscopy System recalled
Beaver-Visitec International is recalling BVI Leos Laser and Endoscopy System, distributed nationwide in the US. The recall was initiated on 5 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1008-2026
- FDA event ID
- 98076
- Recalling firm
- Beaver-Visitec International, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Dec 2025
- FDA classified
- 31 Dec 2025
- Reported
- 7 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Device type
- Surgical Instruments
Timeline
| 5 Dec 2025 | Recall initiated by company | |
| 31 Dec 2025 | Classified by FDA | +26 days |
| 7 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Where it was distributed
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
Questions about this recall
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).
Which lots are affected?
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Where was it sold?
US Nationwide distribution in the states of FL, MI, OK, TX, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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