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 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 |
| Classification | Class I |
| Recall number | Z-2224-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern. |
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 -- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 -- and the recall number Z-2224-2026. 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.
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: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004. FDA's stated reason for the recall is: Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2224-2026 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.
Fresenius Kabi USA, LLC’s FDA history
Argus HQ has recorded 29 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 27 recalls, 2 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What is the FDA recall number for this event?
- FDA recall number Z-2224-2026.
- 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.
- What was recalled and why?
- Fresenius Kabi USA, LLC recalled Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004. FDA's record states the reason for recall as: Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen (additional items listed in FDA's full record). The recall.
Know if this happens again — we'll email you.
Free. No spam, just recall alerts for what you tell us to watch.
Related enforcement actions
Full FDA history for Fresenius Kabi USA, LLC- Recall: Fresenius Kabi USA, LLC — Class II recall: Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose… →
- Recall: Fresenius Kabi USA, LLC — Class II recall: Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg… →
- Recall: Fresenius Kabi USA, LLC — Class II recall: Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in… →
- Recall: Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 2… →
- Approval: FRESENIUS KABI USA LLC — NDA approval: Unspecified (unspecified) →
- Recall: Fresenius Kabi USA, LLC — Class II recall: Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 2… →
- Approval: FRESENIUS KABI USA — ANDA approval: SUGAMMADEX SODIUM (unspecified) →
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.
Argus HQ Research (2026). FDA Recall Database: Class I Recall: Ivenix Infusion System (IIS), Large Volume Pump, Model… by Fresenius Kabi USA, LLC. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-fresenius-kabi-usa-llc-z-2224-2026
"FDA Recall Database: Class I Recall: Ivenix Infusion System (IIS), Large Volume Pump, Model… by Fresenius Kabi USA, LLC." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-fresenius-kabi-usa-llc-z-2224-2026.
Argus HQ Research. "FDA Recall Database: Class I Recall: Ivenix Infusion System (IIS), Large Volume Pump, Model… by Fresenius Kabi USA, LLC." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/recall/fda-recall-fresenius-kabi-usa-llc-z-2224-2026.
@misc{argushq_argushq_ai_recall_fda_recall_fresenius_kabi_usa_llc_z_2224_2026_2026,
title = {FDA Recall Database: Class I Recall: Ivenix Infusion System (IIS), Large Volume Pump, Model… by Fresenius Kabi USA, LLC},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-fresenius-kabi-usa-llc-z-2224-2026},
note = {Accessed: August 27, 2026}
}Source: FDA.gov — Recalls ↗