Fresenius Kabi USA, LLC recalls
31 recalls filed under Fresenius Kabi USA, LLC. The most recent was published April 15, 2026.
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 9 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , LVP Software: LVP-SW-0005 recall: Emphasizing instructions for LVP duration programming located in the IFU
Emphasizing instructions for LVP duration programming located in the IFU.
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Class I · 10 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , LVP Software LVP-SW-0005. Software recall: Software version 5.10.1 and earlier contain anomalies that have the potential
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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Class I · 11 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System, LVP Primary Administration Set recall: Incorrect assembly of specific lot of LVP Primary Administration Set
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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Class II · 11 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , Large Volume Pump recall: Downstream Occlusion alarms may occur during procedures using low flow
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
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Class I · 11 months ago
Fresenius Kabi USA, LLC Famotidine Injection, USP, 20 mg per 2 mL , 2 mL vials recall: Microbial Contamination of Sterile Products
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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Class II · 12 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , Large Volume Pump recall: Potential issue that can cause the device to register "phantom" touches
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
About this page
Fresenius Kabi USA, LLC appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.