Class IIOngoingZ-2723-2026

ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump

ICU Medical, Inc.Lake Forest, IL, United StatesReported Jul 22, 2026 · 6 days ago

Legal News Analyst · Jul 22, 2026

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump

Lot / code information

Serial #: 50003704, 50003710, 50004046, 50004072, 50004149, 50004154 — +1640 moreShow all
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…
Serial #: 80000115, 80000116, 80000123, 80000125, 80000128, 80000130 — +1600 moreShow all
80000115, 80000116, 80000123, 80000125, 80000128, 80000130, 80000131, 80000134, 80000135, 80000137, 80000139, 80000140, 80000141, 80000142, 80000143, 80000144, 80000146, 80000147, 80000148, 80000149, 80000153, 80000154, 80000155, 80000157, 80000158, 80000162, 80000164, 80000165, 80000171, 80000172, 80000174, 80000175, 80000177, 80000178, 80000179, 80000180, 80000181, 80000182, 80000184, 80000185, 80000187, 80000188, 80000192, 80000202, 80000203, 80000204, 80000206, 80000207, 80000209, 80000210, 80000211, 80000212, 80000213, 80000215, 80000216, 80000217, 80000218, 80000219, 80000221, 80000223, 80000225, 80000226, 80000228, 80000229, 80000230, 80000231, 80000236, 80000237, 80000241, 80000253, 80000254, 80000256, 80000258, 80000263, 80000267, 80000268, 80000270, 80000277, 80000278, 80000281, 80000284, 80000285, 80000286, 80000287, 80000288, 80000289, 80000293, 80000294, 80000295, 80000296, 80000297, 80000298, 80000299, 80000300, 80000303, 80000304, 80000306, 80000307, 80000308, 80000310, 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…

Additional code information

7, 80003139, 80003140, 80003142, 80003143, 80003144, 80003146, 80003148, 80003151, 80003152, 80003153, 80003154, 80003155, 80003156, 80003158, 80003159, 80003160, 80003161, 80003163, 80003164, 80003165, 80003166, 80003167, 80003168, 80003169, 80003171, 80003172, 80003174, 80003177, 80003178, 80003179, 80003180, 80003181, 80003182, 80003183, 80003184, 80003185, 80003186, 80003189, 80003190, 80003191, 80003192, 80003194, 80003195, 80003196, 80003197, 80003198, 80003199, 80003200, 80003201, 80003202, 80003203, 80003205, 80003206, 80003207, 80003208, 80003210, 80003211, 80003213, 80003214, 80003216, 80003217, 80003218, 80003219, 80003222, 80003223, 80003229, 80003233, 80003235, 80003236, 80003238, 80003239, 80003241, 80003242, 80003244, 80003245, 80003246, 80003247, 80003248, 80003251, 80003252, 80003253, 80003254, 80003256, 80003257, 80003258, 80003259, 80003260, 80003261, 80003262, 80003263, 80003264, 80003265, 80003266, 80003267, 80003268, 80003269, 80003270, 80003271, 80003274, 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8000963 …

What the firm is doing

ICU Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 06/10/2026 via hand delivered letter. The notice explained the issue, potential risk, and requested the following: "Identify all affected infusion pumps in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification. If the pump is in the state shown in Figures 1 and 2, do not press the Start button. Wait for the pump to complete the Cassette Test before taking further action. It is important to note that if the clinician waits for the Cassette Test to complete (and the START button is only pressed once), this potential scenario does not occur. If the pump displays a green background on the line with active animation indicating delivery is occurring and the VTBI is not decrementing, stop delivery and restart the line to resolve this issue. Complete and return the attached Customer Response Form to ICUMedMarketActionsTeam@icumed.com within 10 days of receipt to acknowledge your understanding of this notification." For further inquiries: For any questions regarding this action: https://icumed.custhelp.com/app/market-action. Additional technical information or assistance: Technical Support, 1-(800)-241-4002, option 3 or tsc.support@icumed.com. To report adverse events or product complaints: Global Complaint Management: 1-844-654-7780 (M-F, 8:00 am 5:00 pm CT) or ProductComplaintsPP@icumed.com.

DistributionShow details

Worldwide distribution - US Nationwide and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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