ICU Medical Plum Duo Infusion 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 12,525 Plum Duo Infusion Pumps due to a software issue that may cause delivery of up to twice the intended VTBI.
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 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
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
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403. 12,525 units. Distributed US Nationwide and Canada. Recall number Z-2723-2026. Classification: Class II. Status: Ongoing.
What You Should Do
Contact the recalling firm for further instructions regarding the affected devices.
Why This Matters
This ongoing Class II recall affects over 12,000 infusion pumps distributed nationwide and in Canada.
Source
FDA recall number Z-2723-2026, event ID 99192.
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 (730 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.