The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1839-2021·Announced 2021-06-16

Medical Device Illumination Pack Recalled Due to Burn and Occlusion Risks

Nico Corp. is recalling 439 NICO Myriad-LX Illumination Packs used in surgical procedures due to potential delivery sleeve occlusion and thermal burn injury from the fiber tip assembly.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II with potential for thermal burn injury and device occlusion. No reported injuries or hospitalizations mentioned in source. Classified as high-risk based on potential harm in surgical context despite absent incident reports.

Plain-English summary

Nico Corp. is recalling 439 NICO Myriad-LX Illumination Packs (REF NN-1000 and NN-1001) distributed nationwide. These surgical accessories support tissue resection and fluid removal under direct visualization using the NICO Myriad System.

The recall addresses two hazards: (1) the delivery sleeve may become completely occluded by tissue or debris, particularly in endonasal surgical approaches, reducing or eliminating light output and compromising surgical visibility; and (2) the distal tip of the fiber-sleeve assembly may cause thermal injury to healthy tissue, potentially resulting in minor to moderate patient injury.

The manufacturer has issued updated instructions for use warning surgeons to avoid contact between the delivery sleeve's distal opening and tissue or debris in the surgical field. If unintended reduction in light output or suspected occlusion occurs during a procedure, both the delivery sleeve and fiber should be replaced immediately.

Healthcare providers using affected lot numbers should review the updated instructions and contact Nico Corp. with questions or to request replacement components.

The recalled product

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.
Manufacturer
Nico Corp.
Category
Medical Device — Surgical Illumination System
Hazard
Affected units
439

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Nico Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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