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

Optiflux Dialyzer Recall: Press-On Caps Require Proper Installation

Fresenius Medical Care is recalling Optiflux High Flux E-beam Dialyzer models nationwide because caps were changed from threaded to press-on design, requiring users to press firmly to ensure secure attachment. Improper installation may result in cap detachment and device malfunction.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a risk-of-harm medical device (dialyzer—critical life-sustaining equipment). No injuries, illnesses, or adverse events are reported in the source material, placing it at High rather than Severe severity despite the safety-critical nature of the device.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling Optiflux High Flux E-beam Dialyzer models: OPTIFLUX F160NRe (Model 0500316E), OPTIFLUX F180NRe (Model 0500318E), OPTIFLUX F200NRe (Model 0500320E), and OPTIFLUX F250NRe (Model 0500325E). This recall affects all units manufactured after September 6, 2023, totaling approximately 172.5 million units distributed nationwide.

The dialyzer caps were changed from a threaded design to a press-on design. Users must press the caps firmly onto the dialyzer to securely affix them. The change in cap design requires users to follow proper installation procedures to ensure the caps remain secure during use.

Healthcare facilities and patients using these dialyzers should verify that caps are pressed firmly and securely onto the units before use. For questions about proper installation or additional information, contact Fresenius Medical Care Holdings, Inc. or the FDA.

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 — Dialysis Equipment
Hazard
  • improper-assembly
  • seal-failure

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.

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