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 |
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.
How to identify the recalled item
| Lot / date codes | 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; |
|---|---|
| Lot / date codes | Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.