Stryker Corporation recalls NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0600-2026
• FDA 510(k) clearance · K191599The device's official FDA premarket clearance record
• FDA 510(k) clearance · K232567The device's official FDA premarket clearance record
• FDA device classification · GEIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4400The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Stryker CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.