Recall Z-2312-2026
ICU Medical, Inc. · initiated April 29, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Plum Duo Infusion Pump, 40002-0401
Codes / lots: UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3
Reason for recall
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-determined cause: Software Design Change
Action taken
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.
Details
- Recall number
- Z-2312-2026
- Initiated
- April 29, 2026
- Posted by FDA
- June 5, 2026
- Product code
- FRN – Pump, Infusion
- Quantity
- 13,613
- 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.
- Recalling firm
- ICU Medical, Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2311-2026 Class II | Plum Solo Precision IV Pump, 40001-0401Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of… | 04/29/2026Open, Classified |
| Z-2313-2026 Class II | Plum Duo Precision IV Pump, 40002-0403Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of… | 04/29/2026Open, Classified |