NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's
FDA device recall Z-0601-2026 · posted 2025-11-26 · Open, Classified
Recall details
- Recalling firm
- Stryker Corporation
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 39,148
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
- Date initiated
- 2025-10-31
- Date posted
- 2025-11-26
- Location
- Portage, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NICO Myriad NOVUS (K191599) | Nico Corporation | 2019-09-13 |