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Open, Classified

NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber

FDA Recall Z-0600-2026 · Posted 2025-11-26

Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2025-10-31
Product Quantity39,148

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.

Firm Action

On October 31, 2025, the firm began notifying impacted customers through Urgent Medical Device Recall letters. Customers were instructed to mark affected product with "CONTAINS LATEX" and place a copy of the notice at the product's storage location before use. Product returns are not required. However, customers who would like to receive a replacement were given options to destroy or return product for a replacement.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232567Myriad SPECTRA Light SourceNico Corporation · 2024-03-14K191599NICO Myriad NOVUSNico Corporation · 2019-09-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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