Z-0936-2026Class II

5008X CAREsystem +CLiC +CDX

Name: Z-0936-2026 5008X CAREsystem +CLiC +CDX
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2025-10-25
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2025-10-25 / Open, Classified / root cause: software

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 5008X CAREsystem +CLiC +CDX on 2025-10-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0936-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-25
Posted: 2025-12-17
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 5008X CAREsystem +CLiC +CDX;
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: software
FDA root cause: Software design
Action: On Octiber 25, 2025, customers were called and read a Medical Device Recall Script. Instructions: Please examine the 5008X CAREsystems at your location to confirm that you have any of this product: 1. Please segregate this product until the software update can be performed. 2. Please provide the number of 5008X CAREsystems you have installed at your clinic and the serial numbers of the devices. If the customer has any additional medical concerns or questions, please have them contact Medical Information and Communication: 855-616-2309 or Website: www.freseniusmedinfo.com. Report any complaints or adverse events to [email protected] or FDA MedWatch at https://www.fda.gov/safety/medical-product-safety-information/medwatchforms-fda-safety-reporting
Quantity in commerce: 115 units
Distribution: Domestic: LA, MA, MN;
Product codes and lots: Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0936-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0936-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-17

Product code KDI

K243505Class II5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC / cleared 2025-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)