CLASS II Device recall · Reported 16 Jun 2021 · FDA Enforcement Report
Myriad-LX Illumination Pack recalled by Nico
Nico is recalling NICO Myriad-LX Illumination Pack, distributed nationwide in the US. The recall was initiated on 30 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1839-2021
- FDA event ID
- 87882
- Recalling firm
- Nico, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2021
- FDA classified
- 9 Jun 2021
- Reported
- 16 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Apr 2021 | Recall initiated by company | |
| 9 Jun 2021 | Classified by FDA | +40 days |
| 16 Jun 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Myriad-LX Illumination Pack recalled?
Yes. Nico recalled Myriad-LX Illumination Pack on 30 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1839-2021.
Why was it 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.
Which lots are affected?
Lot Numbers: 37KII300 37KI1301 37LI0320 37LI0322 37AJ1438 37AJ1439 37BJ0513 37BJ0516 37CJ0203 37CJ0204 37GJ1603 37GJ1607 37110208 37IJ0209
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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