Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0936-2026 — 5008X CAREsystem +CLiC +CDX;

U.S. FDA — Device Enforcement · United States · 2025-10-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0936-2026
Date of alert: 2025-10-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Fresenius Medical Care Holdings, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00840861102433

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0936-2026 — 5008X CAREsystem +CLiC +CDX;

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