# FDA recall Z-1839-2021

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

## Product

NICO Myriad-LX Illumination Pack:  REF: NN-1000 Mvriad-LX Illumination Pack. 11ga  REF: NN-1001 Mvriad-LX Illumination Pack. l3ga    Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.

## 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-1839-2021
- **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-1839-2021

## Citation

> AI Analytics. FDA recall Z-1839-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1839-2021. Source: US FDA. Licensed CC0.

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