Recall Z-0600-2026— Stryker Corporation

Name: FDA recall Z-0600-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-31

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2025-10-31. It names 2 FDA 510(k) clearances: K232567, K191599. Product: NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber. Reason: 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
Classification: Class II
Status: Ongoing
Initiated: 2025-10-31
Firm location: Portage, MI, United States

510(k) clearances named in this recall

2 on FDA's record

K232567 — Myriad SPECTRA Light SourceNico Corporation·cleared 2024-03-14
K191599 — NICO Myriad NOVUSNico Corporation·cleared 2019-09-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.