Use cautionMedical device recall · FDA · Published September 12, 2020
Fresenius Liberty Select Cycler Software 2.9.0: Risk of Inadequate Dialysis
Fresenius recalls Liberty Select Cycler software version 2.9.0 (model 180343/RTLR180343) due to potential dialysis solution shortage causing toxin buildup. Affected users should contact for remedy.
The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
Take action
Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer
Fresenius Medical Care recalls specific software versions of their dialysis machines that may cause inadequate dialysis treatment. This could lead to toxin buildup and symptoms like shortness of breath, weight gain, and high blood pressure if not fixed. Read more at govinfonow.com/recall/64301-fresenius-liberty-select-cycler-software-2-9-0-risk-of.
“Fresenius Liberty Select Cycler Software 2.9.0: Risk of Inadequate Dialysis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64301-fresenius-liberty-select-cycler-software-2-9-0-risk-of. Based on FDA recall #Z-0439-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0439-2021%22&limit=1).
The FDA announced on September 12, 2020, that Fresenius Medical Care Holdings, Inc. is recalling Liberty Select Cycler Software Version 2.9.0 devices due to a hazard of inadequate dialysis. The agency said the recall affects 9,907 units distributed nationwide.
How to tell if you have it
Brand: Fresenius Medical Care
Product: Liberty Select Cycler
Software Version: 2.9.0
Model Numbers: 180343 and RTLR180343
The hazard
According to the FDA, the device may detect an incorrect Heater Bag volume, leading to a 'Supply Bag Line Blocked' alarm. This error causes the cycler to not recognize extra fluid, potentially resulting in inadequate dialysis and the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
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 Bicarby Dialysate leaks risk on May 12, 2026, and a 5008X Blood Tubing Set recall for online port errors on May 11, 2026. Other recent recalls of similar products include a Fresenius Medical Care 2008T BlueStar Hemodialysis Machine recall (June 30, 2026) and two August 10, 2026 recalls for the 5008X HD/HDF with Twister Tubing Set and the 5008X Blood Tubing Set involving blood leak risks.
How to tell if you have this one
Check if your Liberty Select Cycler has software version 2.9.0 with model numbers 180343 or RTLR180343. The recall covers all units sold with these specific software versions.
Brand
Fresenius Medical Care
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Fresenius
Reach out to Fresenius Medical Care for instructions on software updates or replacements.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months 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-0439-2021 (September 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0439-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.