The Recall Desk
Severity pendingFDA (Devices)·Z-0041-2026·Announced 2025-10-15

Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM,

Pending LLM rewrite. Source: FDA_DEVICE Z-0041-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

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
Manufacturer
Fresenius Medical Care Holdings, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • 1. Model: 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM
  • UDI-DI: 840861100149
  • All Lots manufactured after SEP/06/2023
  • 2. Model: 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM
  • UDI-DI: 840861100156
  • 3. Model: 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM
  • UDI-DI: 840861100163
  • 4. Model: 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
  • UDI-DI: 840861100170

Distribution

Distributed nationwide across the United States.

Related recalls

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