Drug recall
5008X CAREsystem +CLiC +CDX;
FDA recall event 97934 · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Event ID | 97934 |
|---|---|
| Recall numbers | Z-0936-2026 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Product type | Devices |
| Products | 5008X CAREsystem +CLiC +CDX; |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 25, 2025 |
| Report date | Dec 24, 2025 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3001451489 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: