CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report

5008X CAREsystem +CLiC +CDX recalled by Fresenius Medical Care

Fresenius Medical Care Holdings is recalling 5008X CAREsystem +CLiC +CDX, distributed in Louisiana, Massachusetts, Minnesota. The recall was initiated on 25 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;

Quantity recalled115 units

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-0936-2026
FDA event ID: 97934
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Oct 2025
FDA classified: 17 Dec 2025
Reported: 24 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

25 Oct 2025	Recall initiated by company
17 Dec 2025	Classified by FDA	+53 days
24 Dec 2025	Published in enforcement report	+7 days

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

Reason for recall

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

5008X CAREsystem +CLiC +CDX;

Where it was distributed

Domestic: LA, MA, MN;

Louisiana Massachusetts Minnesota

Questions about this recall

Why was it recalled?

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

Which lots are affected?

Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;

Where was it sold?

Domestic: LA, MA, MN;

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

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