ICU Medical Recalls Plum Duo Precision IV Pump
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ICU Medical, Inc. is recalling 13,613 Plum Duo Precision IV Pumps after the device may fail to display a soft limit alert under certain conditions.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 28, 2026 and geographically references United States and Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
ICU Medical, Inc. initiated a voluntary recall of the Plum Duo Precision IV Pump because under certain conditions, the pump may not display a soft limit alert and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Which Products Are Affected
The recall involves the Plum Duo Precision IV Pump, model 40002-0403, with UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3. A total of 13,613 units are affected. Distribution includes US nationwide in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and Canada. The recall number is Z-2313-2026 and it is classified as Class II.
What You Should Do
The recalling firm initiated the action via letter. No additional consumer instructions are provided in the recall notice.
Why This Matters
The recall affects more than 13,000 infusion pumps distributed across multiple U.S. states and Canada, with the potential for incorrect medication delivery.
Source
FDA recall Z-2313-2026, event ID 98872. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,108 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 28, 2026.
Frequently Asked Questions
Common questions about this FDA recall.