Lower riskMedical device recall · FDA · Published August 29, 2025
Fresenius Optiflux Dialyzer Recall: Press-on Caps May Not Secure Properly
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.
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Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/51518-fresenius-optiflux-dialyzer-recall-press-on-caps-may-not-secure.
“Fresenius Optiflux Dialyzer Recall: Press-on Caps May Not Secure Properly.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51518-fresenius-optiflux-dialyzer-recall-press-on-caps-may-not-secure. Based on FDA recall #Z-0041-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0041-2026%22&limit=1).
The FDA announced on Aug. 29, 2025, that Fresenius Medical Care Holdings Inc. is voluntarily recalling Optiflux High Flux E-beam Dialyzers to ensure proper use of the medical device. The company changed the caps from a threaded version to a press-on version requiring firm pressing to secure them.
The recall addresses the change in cap design from a threaded version to a press-on version. Users must press the caps firmly onto the dialyzer to securely affix the cap and ensure proper use of the device.
Context
GovInfoNow's records show Fresenius Medical Care Holdings Inc. has 44 other recalls on record since April 14, 2014. Recent brand recalls include a May 12, 2026, notice regarding Bicarby Dialysate leaks and a May 11, 2026, recall of the 5008X Blood Tubing Set for online port errors. Other recent recalls of similar products include Vantive Healthcare's Jan. 6, 2026, Prismaflex M10 Dialyzer recall and Vantive US Healthcare's Jan. 6, 2026, Prismaflex HF1000 Set and ST100 Set recalls for dialyzer chamber dislodgement risks.
How to tell if you have this one
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.
Brand
Fresenius Medical Care
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Identify the model number on your dialyzer to see if it matches the recalled models: 0500316E, 0500318E, 0500320E, or 0500325E.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0041-2026 (August 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0041-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.