Home / Recalls / Fresenius Kabi USA, LLC / Z-2223-2026

Z-2223-2026 Class I Ongoing

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

FDA device recall Z-2223-2026 was initiated by Fresenius Kabi USA, LLC on May 6, 2026 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 32 systems.

Recall Details

Product Type
Devices
Report Date
June 10, 2026
Initiation Date
May 6, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 systems

Product Description

LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

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.

Distribution Pattern

US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

Code Information

Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2

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)
  • 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)
  • 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-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-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-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-0430-2026 Class II — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a (March 11, 2026)

FDA data resources