NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No....
FDA Recall #Z-0600-2026 — Class II — October 31, 2025
Product Description
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
Reason for Recall
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
39,148
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
Code Information
Product Number/UDI-DI (GTIN)/Lot Numbers: NN-1000 00816744021009 37AC5163 37AE9811 37AJ1438 37BJ0513 37CB3410 37CB3416 37CD6003 37CE3030 37EB5720 37FA4260 37GD2216 37GJ1603 37IC7023 37IJ0208 37JJ0122 37KI1300 37LA0158 37LI0320 37LJ1522; NN-1001 00816744021016 37AC5177 37AE9942 37AE9955 37AJ1439 37BJ0516 37CB3380 37CB3419 37CD6005 37CJ0204 37DE4864 37EB5721 37FA4261 37GD2219 37GJ1607 37IC7027 37IJ0209 37JD5753 37JJ0123 37KI1301 37LA0159 37LI0322 37LJ1525
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated