RecallDepth

Icu Medical Inc

LAKE FOREST, IL, United States

This page shows every FDA and USDA recall linked to Icu Medical Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.

56
Total Recalls
2017
First Recall
2026
Most Recent
4
Class I (Most Serious)
Drug: 10 Device: 46 Class II: 6
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Jan 16, 2026 · Device
Open, Classified
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Jan 16, 2026 · Device
Open, Classified
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Jan 16, 2026 · Device
Open, Classified
Plum Duo Infusion System, List Number 40002-04-01
Jan 15, 2026 · Device
Open, Classified
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Dec 19, 2025 · Device
Open, Classified
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Dec 19, 2025 · Device
Open, Classified
Plum Duo Infusion System, List Number: 400020401
Aug 6, 2025 · Device
Open, Classified
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Jun 18, 2025 · Device
Open, Classified
ICU Medical Plum Solos, Item number 400011001; infusion pump
Jun 18, 2025 · Device
Open, Classified
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
May 14, 2025 · Device
Open, Classified
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lak...
Mar 19, 2025 · Drug
Class I Ongoing
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360...
Nov 21, 2024 · Device
Open, Classified
Plum 360/A+ spare batteries. Item Number: SUB0000864.
Aug 9, 2024 · Device
Open, Classified
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump L...
Aug 9, 2024 · Device
Open, Classified
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product desc...
Aug 9, 2024 · Device
Open, Classified
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300...
Aug 18, 2023 · Device
Open, Classified
ASM Replacement Battery, Component Number SUB0000864
May 16, 2023 · Device
Open, Classified
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 1100...
May 16, 2023 · Device
Open, Classified
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
May 16, 2023 · Device
Open, Classified
ASM Replacement Battery, Component Number SUB0000594
May 16, 2023 · Device
Open, Classified
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, I...
Nov 23, 2022 · Drug
Class II Ongoing
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc.,...
Sep 22, 2021 · Drug
Class I Terminated
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., L...
Mar 31, 2021 · Drug
Class II Terminated
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, ND...
May 27, 2020 · Drug
Class I Terminated
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. ND...
Nov 13, 2019 · Drug
Class I Terminated
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Oct 22, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Pr...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PR...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PL...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Pr...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Pr...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Pr...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Hi...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Pr...
Jul 29, 2019 · Device
Terminated
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled a...
Jul 29, 2019 · Device
Terminated
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045...
Feb 27, 2019 · Drug
Class II Terminated
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake...
Nov 14, 2018 · Drug
Class II Terminated