ICU Medical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0482-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197

Product Classification:

Class I

Date Initiated: October 22, 2024

Date Posted: November 27, 2024

Recall Number: Z-0482-2025

Event ID: 95586

Reason for Recall:

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

Status: Ongoing

Product Quantity: 3840

Code Information:

All batteries WITHOUT the following information on the label: 1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery): W2401xxxx - W2406xxx

Distribution Pattern:

Worldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingdom, and Uruguay.

Voluntary or Mandated:

Voluntary: Firm initiated