Home / Recalls / Fresenius Kabi USA, LLC / Z-0885-2026

Z-0885-2026 Class I Ongoing

Recalled by Fresenius Kabi USA, LLC — North Andover, MA

FDA device recall Z-0885-2026 was initiated by Fresenius Kabi USA, LLC on November 14, 2025 and is designated Class I. Reason for recall: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. The recall status is ongoing. Affected quantity: 30 units.

Recall Details

Product Type: Devices
Report Date: December 24, 2025
Initiation Date: November 14, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 30 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.

Code Information

Software Versions 5.10.1 and prior; UDI: 00811505030122.

Other recalls by Fresenius Kabi USA, LLC

D-0581-2026 Class III — Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka (May 14, 2026)
Z-2224-2026 Class I — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 (May 6, 2026)
Z-2223-2026 Class I — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. (May 6, 2026)
D-0424-2026 Class II — 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 25 (March 11, 2026)
D-0436-2026 Class II — 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL free (March 11, 2026)
D-0434-2026 Class II — 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in (March 11, 2026)
D-0425-2026 Class II — 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, (March 11, 2026)
D-0433-2026 Class II — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in (March 11, 2026)
D-0428-2026 Class II — 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL (March 11, 2026)
D-0427-2026 Class II — 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL (March 11, 2026)