Nico Corp.: Medical Device Recall in 2021 - (Recall #: Z-1840-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 30, 2021

Date Posted: June 16, 2021

Recall Number: Z-1840-2021

Event ID: 87882

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.

Status: Terminated

Product Quantity: 80 units

Code Information:

Serial Numbers 350-00194D 350-00355D 350-00356D 350-00357D 350-00376D through 350-00444D 350-00451D through 350-00460D 350-00463D through 350-00467D 350-004710 through 350-00475D

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated