AXS Infinity LS Long Sheath: — Class II medical device recall Z-3281-2018
Terminated recall by Stryker Neurovascular, reported 2018-10-10, distributed in CO, NJ, NY, OH, PA, WV. The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
| Recall number | Z-3281-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2018-05-02 |
| Classified | 2018-09-28 |
| Reported by FDA | 2018-10-10 |
| Distributed | CO, NJ, NY, OH, PA, WV |
| Quantity | 15 units |
| UPC / GTIN / UDI-DI | 07613327298253 |
| Lot numbers | 20156091, GEN-10800-80-S2 |
Product
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.
Reason for recall
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
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-3281-2018. 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.