Fresenius Kabi USA, LLC: FDA Enforcement History

FDA action counts (Argus HQ database)

Recall severity breakdown

Computed from all 22 tracked recalls. FDA classifies each recall Class I (most serious), II, or III on the underlying record; Argus HQ maps that to critical/high/medium/low severity buckets.

Recall velocity by month

Months with at least one tracked recall for Fresenius Kabi USA, LLC, oldest to most recent. Gaps indicate months with zero tracked recalls, not missing data.

Recurring recall-reason patterns

Argus HQ keyword-matched the free-text “reason for recall” field on each tracked record into categories below. FDA does not publish a structured reason code for device recalls, so this is Argus HQ’s own pattern analysis, not an official FDA classification — records that don’t match a listed keyword fall into “Other.”

Full recall history (22)

Most recent first. Every row links to its Argus HQ record and FDA.gov source.

Coverage

No independent news coverage was found for Fresenius Kabi USA, LLC’s FDA recall history at the time this page was published — its enforcement record is small enough that it hasn’t drawn trade-press attention. This page is the most complete public record available.

Related enforcement actions

• Fresenius Medical Care Holdings, Inc. — Class II recall: Bicarby Dialysate; Model number: RFP-400-G; →
• Fresenius Medical Care Holdings, Inc. — Class II recall: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G,… →
• Fresenius Kabi USA, LLC — Class III recall: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka… →
• Fresenius Kabi USA, LLC — Class II recall: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: L… →
• Fresenius Kabi USA, LLC — Class I recall: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 →
• Fresenius Kabi USA, LLC — Class I recall: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. →
• Fresenius Medical Care Holdings, Inc. — Class II recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… →
• Fresenius Medical Care Holdings, Inc. — Class II recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange… →
• Fresenius Kabi USA, LLC — Class II recall: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a… →
• Fresenius Kabi USA, LLC — Class II recall: 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL free… →

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