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

Recall Insight

This FDA Devices action (record #Z-1119-2026) was formally reported on January 28, 2026, with the manufacturer initiating the action on December 15, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. ICU Medical, Inc. is listed as the recalling firm, operating out of Lake Forest, IL. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.

The documented reason for this recall is: 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 th… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the country of Philippines.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.