ICU Medical, Inc.: Medical Device Recall in 2026 - (Recall #: Z-1119-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

Product Classification:

Class II

Date Initiated: December 15, 2025

Date Posted: January 28, 2026

Recall Number: Z-1119-2026

Event ID: 98128

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.

Status: Ongoing

Product Quantity:

Code Information:

400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Philippines.

Voluntary or Mandated:

Voluntary: Firm initiated