Fresenius Kabi
33 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Fresenius Kabi and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-03FDA-DrugClass IFamotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- 2025-11-05FDA-DeviceClass IIIvenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- 2022-10-12FDA-DeviceClass IStop using Ivenix Infusion System version 5.2.0
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
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