Stryker Sustainability Solutions — Class II medical device recall Z-2268-2024
Ongoing recall by Stryker Sustainability Solutions, reported 2024-07-10. Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
| Recall number | Z-2268-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Phoenix, AZ, United States |
| Recall initiated | 2024-05-10 |
| Classified | 2024-07-03 |
| Reported by FDA | 2024-07-10 |
| Countries outside the US | JP |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 00885825011680 |
| Serial numbers | 4116975, 4175402, 4175410, 4175411, 4202651, 4202652 |
| Model numbers | D134301 |
Product
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
Reason for recall
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
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-2268-2024. 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.