Fresenius Medical Care recalls Optiflux High Flux E-beam Dialyzers with press-on caps that may not secure properly. Affected models were manufactured after September 6, 2023. No remedy specified in recall notice.
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.
Fresenius Medical Care is recalling four specific models of Optiflux High Flux E-beam Dialyzers because the caps were changed to a press-on design that may not stay securely attached. This could lead to improper use during dialysis treatments if the caps become loose.
The dialyzer caps were redesigned from threaded to press-on versions. Users must press the caps firmly to secure them, but if not done properly, the caps may become loose during dialysis, potentially causing improper treatment or equipment damage.
Patients using these dialyzers for kidney treatment. Those with the specific model numbers and manufacturing dates listed in the recall are most at risk.
Check for model numbers: 0500316E, 0500318E, 0500320E, or 0500325E. These dialyzers were manufactured after September 6, 2023. The recall includes specific lot numbers and UDI-DI codes.
Identify the model number on your dialyzer to see if it matches the recalled models: 0500316E, 0500318E, 0500320E, or 0500325E.
The recall was issued because the caps were changed from a threaded design to a press-on version that may not stay securely attached during use.
The recall notice does not specify any remedy or action steps for affected users.
The affected models are: 0500316E, 0500318E, 0500320E, and 0500325E, all manufactured after September 6, 2023.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-0041-2026 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-0041-2026 from Fresenius Medical Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
