DAC 044 115cm — Class II medical device recall Z-1908-2024
Ongoing recall by Stryker Neurovascular, reported 2024-06-05, distributed nationwide. Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing
| Recall number | Z-1908-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2024-04-23 |
| Classified | 2024-05-28 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CZ, DE, DK, ES, FI, FR, GB, HK, HU, IE, IL, IN, IT, JP, KR, LT, LU, NL, NO, PL, PT, RO, SA, SE, SG, SK, TH, TR, TW |
| Quantity | 81 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 07613327313918 |
| Lot numbers | 156628 |
| Model numbers | 90760 |
Product
DAC 044 115cm, Catalog: 90760
Reason for recall
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
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-1908-2024. 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.