Oxymetry Cable — Class II medical device recall Z-1928-2020
Terminated recall by Edwards Lifesciences, LLC, reported 2020-05-20, distributed nationwide. Intermittent communication due to inconsistent crimping of connectors onto cables.
| Recall number | Z-1928-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2019-10-07 |
| Classified | 2020-05-08 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2021-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, GB, NL |
| Quantity | 35 |
| UPC / GTIN / UDI-DI | 00690103196986 |
Product
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.
Reason for recall
Intermittent communication due to inconsistent crimping of connectors onto cables.
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-1928-2020. 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.