5008X CAREsystem +CLiC +CDX — Class II medical device recall Z-0936-2026
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2025-12-24, distributed in LA, MA, MN. Several software anomalies with the potential to impact patient treatment, of which one includes the possibili
| Recall number | Z-0936-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2025-10-25 |
| Classified | 2025-12-17 |
| Reported by FDA | 2025-12-24 |
| Distributed | LA, MA, MN |
| Quantity | 115 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840861102433 |
| Model numbers | M204441 |
Product
5008X CAREsystem +CLiC +CDX;
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0936-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.