ICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
ICU Medical is recalling Plum Duo Infusion Pump v1.2.3 units due to a software defect that may cause the pump to deliver up to twice the programmed volume without decrementing the display, risking patient overdose.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II recall of a medical device with a defect that could cause delivery of up to twice the prescribed medication dose, creating serious risk of patient harm. Although no illnesses are reported, the potential for serious injury in an infusion pump—a critical device—satisfies the Severe threshold.
Plain-English summary
ICU Medical, Inc. is recalling the Plum Duo Infusion Pump, model v1.2.3 (Item Numbers 400020401 and 400020403), distributed worldwide to the United States and Canada. The recall affects 12,525 units identified by specific serial numbers and UDI codes.
In certain circumstances, the pump's software will fail to decrement the Volume to be Infused (VTBI) value displayed on the Delivery screen. This malfunction may result in the pump delivering up to twice the programmed volume at the set infusion rate, creating a risk of patient harm through medication overdose.
No specific illnesses or injuries have been reported in the source documentation. However, this is a Class II FDA recall of a critical medical device used in clinical settings where accurate drug delivery is essential.
Facilities and individuals who have received affected units should stop using them immediately and contact ICU Medical, Inc. for guidance on replacement or repair. Healthcare providers should verify serial numbers against the recall list provided in the FDA notice (Z-2723-2026).
The recalled product
- Product
- ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- drug-overdose
- software-defect
- delivery-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) UDI/DI +M335400021
- Serial Numbers: 50003704
- 50003710
- 50004046
- 50004072
- 50004149
- 50004154
- 50004156
- 50004163
- 50004166
- 50004168
- 50004177
- 50004183
- 50004205
- 50004218
- 50004220
- 50004249
- 50004258
- 50004262
- 50004263
Distribution
Distributed nationwide across the United States.
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