Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic… — Class II medical device recall Z-0467-2019
Terminated recall by Stryker Sustainability Solutions, reported 2018-11-21, distributed in KS. Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determin
| Recall number | Z-0467-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2018-08-23 |
| Classified | 2018-11-14 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2021-02-04 |
| Distributed | KS |
| Quantity | 2 |
| Reason classes | unapproved product |
| Serial numbers | 2519054, 2534027, D134903 |
| Model numbers | D134909 |
Product
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Reason for recall
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
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-0467-2019. 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.