# FDA recall Z-1840-2021

> **Nico Corp.** · Class II · device recall initiated 2021-04-30.

## Product

Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection  Part Number NN-7013    The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietary connector to ensure usage is reserved for the Myriad-LX Illumination Fiber.

## Reason for recall

(1) Updated IFU for the LX Illumination Packs:   Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced    (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly  potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1840-2021
- **Recalling firm:** Nico Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-30
- **Report date:** 2021-06-16
- **Termination date:** 2024-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1840-2021

## Citation

> AI Analytics. FDA recall Z-1840-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1840-2021. Source: US FDA. Licensed CC0.

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