Sharesource Connectivity Platform for Use with Homechoice Claria… — Class II medical device recall Z-0409-2026
Ongoing recall by Vantive US Healthcare LLC, reported 2025-11-05, distributed nationwide. Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s u
| Recall number | Z-0409-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vantive US Healthcare LLC, Deerfield, IL, United States |
| Recall initiated | 2025-08-28 |
| Classified | 2025-10-29 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, CO, DE, ES, FR, GB, HK, IE, IT, KR, NL, NZ, TH, TR, TW |
| Quantity | 1 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15413765545723 |
Product
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
Reason for recall
Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
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-0409-2026. 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.