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All product recalls associated with ICU Medical Inc..
Total Recalls
1000
Past Year
1000
Class I (Serious)
34
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
International Motors, LLC (International) is recalling certain 2018 International 4000 Series 4300, 2017-2025 MV, 2018-2024 1300 FBC, 2018-2025 IC Bus TC, and 2024-2025 IC Bus CECB vehicles. The brake pressure switch assembly may leak brake fluid into the brake pressure switch's electrical components and cause an electrical short-circuit.
The catheters may not retain their shape.
Unapproved Drug Claims and Misbranded.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Unapproved Drug Claims.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Unapproved Drug Claims.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.