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All product recalls associated with ICU Medical, Inc..
Total Recalls
1000
Past Year
899
Class I (Serious)
125
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.
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
Custom Truck and Body Works (Custom Truck) is recalling certain 2020 Ford F-550 vehicles equipped with Weldon 8X16 Input-Output nodes. In the event of a short circuit or wiring failure, the firmware in the node may fail to shut off the output pin, resulting in overloaded electrical circuits.
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
Marketed Without an Approved NDA/ANDA
This recall involves KICIMPRO kitchen faucets, model number KM800-01-06BN. The faucets are brushed nickel, single-handle kitchen faucets with a pull-down detachable spray and single-hole installation. Consumers can identify whether they have a recalled faucet by searching their Amazon purchase history for "Kicimpro" and "kitchen faucet" and looking for a description including pull-down sprayer, brushed nickel, high-arc, single-handle sink faucet with water lines, commercial modern RV stainless steel, grifos de cocina.
This recall involves VFAUOSIT kitchen faucets, model number 06BNV. The faucets are brushed nickel, single-handle kitchen faucets with a pull-down detachable spray and single-hole installation. Consumers can identify whether they have a recalled faucet by searching their Amazon purchase history for "Vfauosit" and "kitchen faucet" and looking for a description including pull-down sprayer, brushed nickel, stainless steel modern, high-arc, single-handle, single-hole, pull-out kitchen faucet for bar laundry RV utility sink.
This recall involves BASDEHEN kitchen faucets, model number CFDTTH-000-YGH. The faucets are matte black single-handle kitchen faucets with 360° swivel, spring spout design, detachable spray, optional mounting plate and single-hole installation. Consumers can identify whether they have a recalled faucet by searching their Amazon purchase history for "Basdehen" and "kitchen faucet."
Presence of a foreign substance: black hair found embedded in tablet.
Undeclared Allergen (Milk). Consumer found a breaded halloumi Cheese Stick in the bag of churro bites. The Halloumi Cheese contains milk which is not an allergen in the churros.
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
Pseudomonas in Mineral Water. The firm was notified by their distributor that product placed on hold was released and shipped to customers.
Foreign Material (metal)
Potential contamination with Salmonella.
Atlantic Salmon Portions with Seafood Stuffing was incorrectly labeled and does not declare allergen ingredient (SOY)
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.