Plum Duo Infusion Pump, 40002-0401 recallZ-2312-2026 · ICU Medical, Inc. · initiated Apr 29, 2026
Class II Open, Classified All recalls posted in June 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
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.
FDA root cause category: Software Design Change
What the company is doing
On April 29, 2026, the firm notified consignees via letters titled "URGEND MEDICAL DEVICE CORRECTION." Customers were instructed to identify all affected pumps in their possession and ensure all users or potential users of the pumps are immediately made aware of the notification. During bolus programming, clinicians should check whether the soft limit override icon is displayed next to the bolus dose entry field on the programming screen. If the pump displays the icon, the clinician should review the program and make any necessary adjustments before confirming the program. The firm is developing a software update to correct the issue and will notify customers when it is available.
Recall details
- Recall number
- Z-2312-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 29, 2026
- Posted by the FDA
- Jun 5, 2026
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 13,613
- Product code
- FRN
- FDA submissions
- K223607
- Distribution
- Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Product description
Plum Duo Infusion Pump, 40002-0401
Code information (models, lots, serial numbers)
UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3
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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