CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report

Fresenius Liberty¿ Cycler recalled by Fresenius Medical Care

Fresenius Medical Care Holdings is recalling Fresenius Liberty¿ Cycler, distributed nationwide in the US. The recall was initiated on 14 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalled16,600

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0148-2014
FDA event ID: 66339
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 14 Oct 2013
FDA classified: 4 Nov 2013
Reported: 13 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

14 Oct 2013	Recall initiated by company
4 Nov 2013	Classified by FDA	+21 days
13 Nov 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.

Where it was distributed

USA Nationwide Distribution

Nationwide

Questions about this recall

Is Fresenius Liberty¿ Cycler recalled?

Yes. Fresenius Medical Care Holdings recalled Fresenius Liberty¿ Cycler on 14 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0148-2014.

Why was it recalled?

Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis

Which lots are affected?

All serial numbers

Where was it sold?

USA Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Fresenius Medical Care Holdings

All 165

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	5008X Blood Tubing Set recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
17 Jun 2026Device	CLASS II	Bicarby" Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
17 Jun 2026Device	CLASS II	Bicarby Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	TX
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide