ICU Medical Plum Solo Precision IV Pump Recall
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 5,059 Plum Solo Precision IV Pumps due to a software issue that may cause the device to deliver up to twice the programmed Volume to be Infused.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 10, 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-device.
What Happened
ICU Medical, Inc. initiated a voluntary recall of its Plum Solo Precision IV Pump after identifying a software issue in version 1.0.3. In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Which Products Are Affected
The recall affects the ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401. A total of 5,059 units are involved. The recall covers specific serial numbers beginning with 60000 and distributed worldwide, including US Nationwide and Canada. The recall number is Z-2724-2026. This is an ongoing Class II recall initiated on June 10, 2026.
What You Should Do
Consumers and healthcare facilities should contact ICU Medical, Inc. regarding the affected pumps. The recalling firm is located at 600 N Field Dr, Lake Forest, IL 60045-4835.
Why This Matters
This Class II recall addresses a device malfunction that could result in incorrect medication delivery volumes during infusion therapy.
Source
FDA recall number Z-2724-2026. Data from FDA enforcement report.
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 (1,153 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.