Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga Recalled by Nico Corp. Due to (1) Updated IFU for the LX Illumination Packs:...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nico Corp. directly.
Affected Products
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.
Quantity: 439 packs
Why Was This Recalled?
(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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nico Corp.
Nico Corp. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report