# FDA recall Z-1008-2026

> **Beaver-Visitec International, Inc.** · Class II · device recall initiated 2025-12-05.

## 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).

## Distribution

US Nationwide distribution in the states of FL, MI, OK, TX, WI.

## Key facts

- **Recall number:** Z-1008-2026
- **Recalling firm:** Beaver-Visitec International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-05
- **Report date:** 2026-01-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2026

## Citation

> AI Analytics. FDA recall Z-1008-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1008-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*