Use cautionMedical device recall · FDA · Published April 30, 2021
Nico Myriad-LX Light Source Recall: Risk of Tissue Damage from Sleeve Occlusion
Nico Corp. recalls Myriad-LX Light Sources with serial numbers 350-00194D to 350-00475D due to potential tissue damage from sleeve occlusion during surgery. Updated instructions prevent light output reduction and sleeve blockage.
(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.
Take action
Contact the company
📍Recalling firmNico Corp.250 E 96th St Ste 125 · Indianapolis, IN 46240-3872
✎ GovInfoNow plain-language explainer
Nico Corp. is recalling Myriad-LX Light Sources with specific serial numbers because improper use could cause the light delivery sleeve to block, reducing light output and potentially damaging tissue. This risk is most concerning during certain surgical procedures like endonasal approaches. Read more at govinfonow.com/recall/62627-nico-myriad-lx-light-source-recall-risk-of-tissue-damage.
“Nico Myriad-LX Light Source Recall: Risk of Tissue Damage from Sleeve Occlusion.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62627-nico-myriad-lx-light-source-recall-risk-of-tissue-damage. Based on FDA recall #Z-1840-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1840-2021%22&limit=1).
Nico Corp. recalled the Myriad-LX Light Source on April 30, 2021, according to the FDA. The device poses a risk of burning healthy tissue or reducing light output during surgery. Owners should update the Instructions for Use.
How to tell if you have it
Brand: Nico Corp.
Product: Myriad-LX Light Source
Part Number: NN-7013
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
The hazard
The recall addresses the potential for the distal tip of the sleeve/fiber assembly to burn healthy tissue, resulting in minor to moderate injury to the patient or end user. Unintended reduction in light output may also occur if occlusion is suspected.
Context
GovInfoNow's records show Nico Corp. has one other recall on record since June 19, 2018. That earlier recall involved a mislabeled pouch lacking product information (June 19, 2018). Other recent recalls of similar products include the Stryker CHROMOPHARE Softlit Ring Surgical Light Recall (Feb. 23, 2026), the Covidien V-Loc 90 Wound Closure Device Recall (June 24, 2026), and the Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025).
How to tell if you have this one
Check the serial number on the Myriad-LX Light Source, which ranges from 350-00194D to 350-00475D. The device is a high-intensity surgical light used for tissue visualization during resection procedures.
Brand
Nico Corp.
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide Distribution
Recall number
Product, codes & lots
Quantity
Z-1839-2021
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.; Lot Numbers: 37KII300 37KI1301 37LI0320 37LI0322 37AJ1438 37AJ1439 37BJ0513 37BJ0516 37CJ0203 37CJ0204 37GJ1603 37GJ1607 37110208 37IJ0209
439 packs
Z-1840-2021
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.; 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
80 units
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Identify the serial number on the device, which should be between 350-00194D and 350-00475D.
Replace Delivery Sleeve
If the sleeve appears blocked or light output is reduced, replace both the delivery sleeve and fiber immediately.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1840-2021 (April 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1840-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.