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Use caution Medical device recall · FDA · Published May 6, 2026

Fresenius Kabi Ivenix Infusion Pump Recall: Touchscreen Malfunction After Drops

Fresenius Kabi recalls Ivenix LVP-0004 infusion pumps that may malfunction after drops or jarring, causing random touchscreen inputs. Affected units have specific model and serial numbers.

🇺🇸 FDA recall #Z-2224-2026Medical deviceFresen:ius Kabi ›
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Contact the company

Recalling firmFresenius Kabi USA, LLC50 High St Ste 50 · North Andover, MA 01845-2620
✎ GovInfoNow plain-language explainer

Fresenius Kabi is recalling Ivenix Large Volume Pumps (model LVP-0004) because drops or jarring can cause touchscreen issues. This may lead to unintended touches or unresponsive screens, which could affect patient safety during medical treatments. Read more at govinfonow.com/recall/49213-fresenius-kabi-ivenix-infusion-pump-recall-touchscreen-malfunction-after-drops.

Source Summary by GovInfoNow · govinfonow.com/recall/49213-fresenius-kabi-ivenix-infusion-pump-recall-touchscreen-malfunction-after-drops · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2224-2026

Cite this page

“Fresenius Kabi Ivenix Infusion Pump Recall: Touchscreen Malfunction After Drops.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49213-fresenius-kabi-ivenix-infusion-pump-recall-touchscreen-malfunction-after-drops. Based on FDA recall #Z-2224-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2224-2026%22&limit=1).

The FDA announced on May 6, 2026, that Fresenius Kabi USA, LLC is recalling the Ivenix Infusion System Large Volume Pump, Model Number LVP-0004. The hazard involves unintended touchscreen behavior caused by drops or jarring.

How to tell if you have it

  • Brand: Fresenius Kabi
  • Product: Ivenix Infusion System (IIS), Large Volume Pump
  • Model Number: LVP-0004
  • UDI-DI: 00811505030320
  • Quantity: 18,444 units

The hazard

Drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in random screen touches and/or lack of responsiveness. These unintended inputs occur intermittently without a predictable pattern. The record states Fresenius Kabi was made aware via customer complaints but reports no specific incidents or injuries.

Context

GovInfoNow's records show Fresenius Kabi USA, LLC has 65 other recalls on record since September 27, 2012. Recent recalls include the August 10, 2026 Tyenne Injection Recall for glass particles and the August 4, 2026 Morphine Syringes recall for wrong labeling. Other recent recalls of similar products include the August 11, 2026 Baxter Novum IQ Syringe Pump Recall for software issues and the July 13, 2026 Medtronic MiniMed 640G Insulin Pump Recall for incorrect insulin delivery risk.

How to tell if you have this one

Check for model number LVP-0004 on the pump. Affected units have specific serial or lot numbers listed in the recall notice.

  • Brand
    Fresen:ius Kabi
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Model Number

    Look for the model number LVP-0004 on the pump's label.

  2. Contact Manufacturer

    Reach out to Fresenius Kabi USA for specific serial/lot numbers and next steps.

Where it went and when

Where it was distributed

Distributed in 21 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: yesMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: May 6, 202612. FDA classified it Class I: May 29, 202623. Published in FDA’s Enforcement Report: Jun 10, 202632026
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2224-2026 (May 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2224-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA