Brand

ICU Medical, Inc.: official recall notices

16 official recall or safety notices on this site name ICU Medical, Inc., dated between 2025-06-03 and 2026-05-12. They were issued by 1 authority: US FDA — Medical Devices (16).

Countries where the notices were issued: United States (16).

Name as written in the notices: ICU Medical, Inc.. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.

Notices by year

Year	Notices
2026	8
2025	8

Notices by authority

Authority	Notices
US FDA — Medical Devices	16

All notices

Date	Authority	Product	Hazard (as classified)
2026-05-12	US FDA — Medical Devices	Oncology sets with drip chambers	—
2026-05-12	US FDA — Medical Devices	Oncology sets with drip chambers	—
2026-05-12	US FDA — Medical Devices	IV Sets with drip chambers	—
2026-05-12	US FDA — Medical Devices	Plum administration sets	—
2026-05-12	US FDA — Medical Devices	IV Sets with drip chambers	—
2026-05-12	US FDA — Medical Devices	IV Non-Dedicated Gravity Administration Sets with drip chambers	—
2026-05-12	US FDA — Medical Devices	IV Sets with drip chambers	—
2026-05-12	US FDA — Medical Devices	IV Sets with drip chambers	—
2025-12-19	US FDA — Medical Devices	Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000	—
2025-12-15	US FDA — Medical Devices	ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)	—
2025-12-15	US FDA — Medical Devices	ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)	—
2025-12-15	US FDA — Medical Devices	ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)	—
2025-11-24	US FDA — Medical Devices	LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02	—
2025-11-24	US FDA — Medical Devices	LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02	—
2025-10-02	US FDA — Medical Devices	IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm	—
2025-06-03	US FDA — Medical Devices	SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200	—

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