Dialyzer Recall: Fresenius Optiflux High Flux F160NRe-F250NRe
Announced 2026-05-13 · FDA
This recall covers Fresenius Optiflux High Flux E-beam Dialyzers, models F160NRe, F180NRe, F200NRe, and F250NRe, distributed nationwide. Caps were changed from threaded to press-on, and users must press the caps firmly onto the dialyzer to securely affix them. All lots manufactured after September 6, 2023 are included.
| Brand | Fresenius Medical Care Holdings, Inc. |
|---|---|
| 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 | 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. |
| Severity | moderate |
| Units affected | 43225 |
| Distribution | US Nationwide distribution. |
| Agency | FDA |
| Recall / campaign no. | 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, All Lots manufactured after SEP/06/2023, 3. Model: 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, UDI-DI: 840861100163, All Lots manufactured after SEP/06/2023, 4. Model: 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM, UDI-DI: 840861100170, All Lots manufactured after SEP/06/2023; |
WHAT YOU SHOULD DO
- Stop using the dialyzer until your dialysis center or supplier instructs otherwise.
- Contact your dialysis center or supplier to verify if your unit is affected and arrange replacement or return.
- Do not modify or force the caps; follow your clinician's instructions for use.
- Report any problems to your healthcare provider and to the FDA MedWatch program if advised.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.