# FDA recall Z-1118-2026

> **ICU Medical, Inc.** · Class II · device recall initiated 2025-12-15.

## Product

ICU Medical Plum Duo Infusion Pump, List Numbers:  400020401 (US), 400021001 (Philippines)

## Reason for recall

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

## Distribution

Worldwide distribution - US Nationwide and the country of Philippines.

## Key facts

- **Recall number:** Z-1118-2026
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-15
- **Report date:** 2026-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1118-2026

## Citation

> AI Analytics. FDA recall Z-1118-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1118-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*