FDA Device recall Z-0601-2026
NICO BrainPath
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of NICO BrainPath by Stryker, citing tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0601-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-31 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker |
| Distribution | US |
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.
Identifiers
| code_info | Product Number/UDI-DI (GTIN)/Lot Numbers: NN-8024 00816744028244 37AI2944 37AJ2013 37BD3753 37BD3778 37CA1605 37CB37…Product Number/UDI-DI (GTIN)/Lot Numbers: NN-8024 00816744028244 37AI2944 37AJ2013 37BD3753 37BD3778 37CA1605 37CB3738 37CH0636 37CI1919 37EH0405 37FC3059 37FD0154 37GA4512 37GH1715 37GI0110 37GJ1623 37HB0029 37HH2313 37HI1536 37HI1631 37IA7694 37ID4162 37IG2900 37JB1413 37JH0131 37JH2903 37KG1406 37KH2953 37LA0708 37LG1834; NN-8025 00816744028251 37BB2326 37BJ1836 37CH0640 37DC0545 37HD2766 37KB3677 37KJ1139; NN-8026 00816744028268 37BJ1837 37CC7852 37CH0643 37DJ1056; NN-8042 07613327663280 37CC9220 37ED9408 37FJ2202 37II2308 37LD8666 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0601-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.