BVI Leos Laser and Endoscopy System — Class II medical device recall Z-1008-2026
Ongoing recall by Beaver-Visitec International, Inc., reported 2026-01-07, distributed nationwide. Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor t
| Recall number | Z-1008-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver-Visitec International, Inc., Waltham, MA, United States |
| Recall initiated | 2025-12-05 |
| Classified | 2025-12-31 |
| Reported by FDA | 2026-01-07 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 00886158037576 |
| Serial numbers | 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010 |
| Model numbers | OME6000U |
Product
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1008-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.