Recall Z-0601-2026— Stryker Corporation

Name: FDA recall Z-0601-2026
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 one FDA 510(k) clearance: K191599. Product: NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;. 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

1 on FDA's record

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 BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;

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.