Recall Z-0601-2026 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Corporation
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;
| Date | Nov 26, 2025 (initiated Oct 31, 2025) |
| Status | Open, Classified |
| Reason | Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. |
| Root cause | Under Investigation by 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191599 | NICO Myriad NOVUS Nico Corporation, Sep 13, 2019 |