ICU Medical Plum Duo Infusion Pump, List Numbers:… recallZ-1118-2026 · ICU Medical, Inc. · initiated Dec 15, 2025
Class II Open, Classified All recalls posted in January 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
FDA root cause category: Software design
What the company is doing
ICU Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/15/2025 via mail, email, telephone, or hand delivery. The notice explained the issue, potential risk and requested the following: "Actions for Users 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 and the sequence of events described. If you do experience this issue, the following mitigations can be performed: " To program the piggyback flush, the clinician must either a) clear infusion program data and power cycle the pump or b) obtain a replacement pump. " The clinician may also continue with the piggyback infusion without using the piggyback flush feature. To manually flush the downstream line, attach and program a flush syringe or bag on Line 2 to flush the fluid from the downstream line at the piggyback rate before restarting the primary line." For device correction inquiries, contact https://icumed.custhelp.com/app/market-action. For technical support, contact: 1-(800)-241-4002, option 3; [email protected]. For complaints, contact: 1-844-654-7780 (M-F, 8:00 am 5:00 pm CT) or [email protected].
Recall details
- Recall number
- Z-1118-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Dec 15, 2025
- Posted by the FDA
- Jan 16, 2026
- Recalling firm
- ICU Medical, Inc.
- Product code
- FRN
- FDA submissions
- K223607
- Distribution
- Worldwide distribution - US Nationwide and the country of Philippines.
Product description
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Code information (models, lots, serial numbers)
400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0
Other devices under the same FDA submission
1 device cleared under K223607 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Plum Duo Infusion System 1.1Icu Medical, Inc. · Pump, infusion3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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