Nico Corp.: Medical Device Recall in 2021 - (Recall #: Z-1839-2021)

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:

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.

Product Classification:

Class II

Date Initiated: April 30, 2021

Date Posted: June 16, 2021

Recall Number: Z-1839-2021

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: 439 packs

Code Information:

Lot Numbers: 37KII300 37KI1301 37LI0320 37LI0322 37AJ1438 37AJ1439 37BJ0513 37BJ0516 37CJ0203 37CJ0204 37GJ1603 37GJ1607 37110208 37IJ0209

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated