ICU Medical Recalls Plum Solo 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 Solo Precision IV Pumps because 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. 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, medical-devices.
What Happened
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
Plum Solo Precision IV Pump, 40001-0401. Quantity: 13,613 units. UDI-DI: M335400011 Plum Solo Precision IV Pump v1.0.3. Distributed nationwide in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and in Canada.
What You Should Do
No specific consumer action steps are provided in the recall notice.
Why This Matters
The Class II recall involves a device that may lead to under- or over-delivery of medication.
Source
FDA recall number Z-2311-2026, event ID 98872. Recalling firm: ICU Medical, Inc., Lake Forest, IL.
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 (809 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.