PRISMAFLEX TPE2000 SET — Class II medical device recall Z-1231-2026
Ongoing recall by VANTIVE US HEALTHCARE LLC, reported 2026-02-11, distributed nationwide. There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
| Recall number | Z-1231-2026 |
|---|---|
| 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 | 2026-01-06 |
| Classified | 2026-02-02 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 13,760 units |
| UPC / GTIN / UDI-DI | 07332414111038 |
Product
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
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-1231-2026. 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.