Optiflux F160NR Dialyzer Recall: Potential Blood Leaks
Fresenius Medical Care recalls Optiflux F160NR dialyzers with specific lot numbers due to potential external blood leaks. Affected units may require replacement.
Use caution until it’s fixed
Potential for external blood leaks from the dialyzer header
Contact the company
What happened, in plain English
Fresenius Medical Care is recalling certain Optiflux F160NR dialyzers that could leak blood externally. This hazard poses a risk to patients using hemodialysis treatments. Read more at govinfonow.com/recall/69500-optiflux-f160nr-dialyzer-recall-potential-blood-leaks.
Source Summary by GovInfoNow · govinfonow.com/recall/69500-optiflux-f160nr-dialyzer-recall-potential-blood-leaks · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0658-2019
Cite this page
“Optiflux F160NR Dialyzer Recall: Potential Blood Leaks.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69500-optiflux-f160nr-dialyzer-recall-potential-blood-leaks. Based on FDA recall #Z-0658-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0658-2019%22&limit=1).
Why it’s dangerous
The dialyzer header may leak blood outside the treatment system during use. This could expose patients to bloodborne pathogens or cause other complications during dialysis.
Who’s affected
Patients receiving hemodialysis treatments using the recalled dialyzers are most at risk. Healthcare providers who use these units should also check their inventory.
How to tell if you have this one
Check for lot numbers 18HU06016, 18HU06017, 18HU06018, or 18HU06019 on the dialyzer packaging. The product code is 0500316E.
- Brand
Fresenius Medical Care- Category
Medical device
What to do — step by step
Check Dialyzer Lot Number
Look for lot numbers 18HU06016, 18HU06017, 18HU06018, or 18HU06019 on the dialyzer packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0658-2019 (November 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0658-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.