Use cautionMedical device recall · FDA · Published December 5, 2024
Fresenius Dialyzer Optiflux 160NRe: Risk of Blood Leaks from Cracks
Fresenius Medical Care recalls Dialyzer Optiflux 160NRe dialyzers with potential internal blood leaks due to cracked polyurethane. Affected units have specific UDI numbers and expire June 30, 2027.
“Fresenius Dialyzer Optiflux 160NRe: Risk of Blood Leaks from Cracks.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53330-fresenius-dialyzer-optiflux-160nre-risk-of-blood-leaks-from-cracks. Based on FDA recall #Z-0801-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0801-2025%22&limit=1).
Fresenius Medical Care Holdings, Inc. voluntarily recalled Dialyzer Optiflux 160NRe units nationwide due to potential internal blood leaks from cracked polyurethane, the FDA said on Dec. 5, 2024.
The recall addresses the potential for internal blood leaks caused by cracked polyurethane in the dialyzers.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Recent similar product recalls include Fresenius Medical Care 5008X HD/HDF with Twister Tubing Set (Aug. 10, 2026), Fresenius Medical Care 5008X Blood Tubing Set Recall (Aug. 10, 2026), and Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (Aug. 10, 2026).
How to tell if you have this one
Check for UDI numbers starting with 24HU06011-00840861100149-270630 or 24HU06010-00840861100149-270630. The dialyzers expire on June 30, 2027.
Brand
Fresenius Medical Care
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check UDI Numbers
Look for UDI numbers starting with 24HU06011-00840861100149-270630 or 24HU06010-00840861100149-270630 on the dialyzer packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “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 41 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-0801-2025 (December 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0801-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.