NICO BrainPath — Class II medical device recall Z-0601-2026
Ongoing recall by Stryker Corporation, reported 2025-12-03, distributed nationwide. Tape used to secure components within packaging contains latex, despite products being labeled as latex-free.
| Recall number | Z-0601-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2025-10-31 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, ES, GB, IE, IT, KW, NL, SG, SI |
| Quantity | 39,148 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00816744028244, 00816744028251, 00816744028268, 07613327663280 |
| Lot numbers | 37AI2944, 37AJ2013, 37BB2326, 37BD3753, 37BD3778, 37BJ1836, 37BJ1837, 37CA1605, 37CB3738, 37CC7852, 37CC9220, 37CH0636, 37CH0640, 37CH0643, 37CI1919, 37DC0545, 37DJ1056, 37ED9408, 37EH0405, 37FC3059, 37FD0154, 37FJ2202, 37GA4512, 37GH1715, 37GI0110, 37GJ1623, 37HB0029, 37HD2766, 37HH2313, 37HI1536, 37HI1631, 37IA7694, 37ID4162, 37IG2900, 37II2308, 37JB1413, 37JH0131, 37JH2903, 37KB3677, 37KG1406 and 9 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0601-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.