Has Fresenius Kabi USA, LLC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 22 total FDA actions tied to Fresenius Kabi USA, LLC, including 22 recalls and 0 warning letters.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

FDA Class I Recall: LVP software of the Ivenix Infusion System (IIS);… by Fresenius Kabi USA, LLC

Key facts

Recalling firm	Fresenius Kabi USA, LLC
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Classification	Class I
Recall number	Z-2223-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

Key takeaway: Fresenius Kabi USA, LLC recalled LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. on 2026-06-10. FDA classified this action as a Class I recall (recall number Z-2223-2026). Reason for recall: Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.. Recall status: Ongoing. This is a device-category FDA recall record.

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Fresenius Kabi USA, LLC and the affected product is described in FDA's record as: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.. FDA's stated reason for the recall is: Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.. The recall is tracked under FDA recall number Z-2223-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. -- and the recall number Z-2223-2026. If it matches, stop using or distributing it and contact Fresenius Kabi USA, LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Fresenius Kabi USA, LLC’s FDA history

Argus HQ has recorded 22 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 22 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Fresenius Kabi USA, LLC had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 22 total FDA actions tied to Fresenius Kabi USA, LLC, including 22 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2223-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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Full FDA history for Fresenius Kabi USA, LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class I Recall: LVP software of the Ivenix Infusion System (IIS);… by Fresenius Kabi USA, LLC. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-fresenius-kabi-usa-llc-z-2223-2026

MLA

"FDA Class I Recall: LVP software of the Ivenix Infusion System (IIS);… by Fresenius Kabi USA, LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-fresenius-kabi-usa-llc-z-2223-2026.

Chicago

Argus HQ Research. "FDA Class I Recall: LVP software of the Ivenix Infusion System (IIS);… by Fresenius Kabi USA, LLC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-fresenius-kabi-usa-llc-z-2223-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_fresenius_kabi_usa_llc_z_2223_2026_2026,
  title = {FDA Class I Recall: LVP software of the Ivenix Infusion System (IIS);… by Fresenius Kabi USA, LLC},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-fresenius-kabi-usa-llc-z-2223-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗