Reported Jul 22, 2026 · Ongoing · Updated Sep 16, 2026
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 600 N Field Dr · Lake Forest, IL · 60045-4835
Is this the product you have?
- ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
- Lot codes and dates
- 1) UDI/DI +M335400021
- Serial Numbers
1,646 of 1,646 codes
500037045000371050004046500040725000414950004154500041565000416350004166500041685000417750004183500042055000421850004220500042495000425850004262500042635000426450004271500043005000430350004304500043055000430750004308500043105000431250004314500043165000431850004319500043235000432450004325500043265000432850004330500043315000433250004333500043345000433550004336500043385000433950004340500043415000434250004344500043455000434650004347500043485000434950004350500043515000435250004356
- Serial Numbers
10,879 of 10,879 codes
800001158000011680000123800001258000012880000130800001318000013480000135800001378000013980000140800001418000014280000143800001448000014680000147800001488000014980000153800001548000015580000157800001588000016280000164800001658000017180000172800001748000017580000177800001788000017980000180800001818000018280000184800001858000018780000188800001928000020280000203800002048000020680000207800002098000021080000211800002128000021380000215800002168000021780000218800002198000022180000223
- Amount recalled
- 12525 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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