Optiflux¿ High Flux E-beam Dialyzer Model Numbers: — Class II medical device recall Z-0041-2026
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2025-10-15, distributed nationwide. To provide further information to the user to ensure proper use of the medical device. the caps had been chang
| Recall number | Z-0041-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2025-08-29 |
| Classified | 2025-10-03 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00840861100149, 00840861100156, 00840861100163, 00840861100170 |
| Model numbers | 0500316E, 0500318E, 0500320E, 0500325E |
Product
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
Reason for recall
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
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-0041-2026. 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.