FDA Device Recall Z-0885-2026

Fresenius Kabi USA, LLC · North Andover, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

Lot / serial / GTIN: Software Versions 5.10.1 and prior; UDI: 00811505030122.

Quantity: 30 units

Reason for recall

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Recall record

Recall number: Z-0885-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Recall initiated: 2025-11-14
Classified by FDA Center: 2025-12-16
FDA published: 2025-12-24
Recalling firm: Fresenius Kabi USA, LLC
Firm location: North Andover, MA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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