Smiths Medical ASD Inc.: Medical Device Recall in 2022 - (Recall #: Z-0653-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.

Product Classification:

Class II

Date Initiated: December 3, 2015

Date Posted: February 23, 2022

Recall Number: Z-0653-2022

Event ID: 89144

Reason for Recall:

There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.

Status: Ongoing

Product Quantity: 38,797 (31,065 pumps and 7,732 boards)

Code Information:

Medfusion 3500 and 4000 Syringe Infusion Pumps manufactured between April 2012 and June 2015; and Medfusion 3010 and 3010A (and pump models 3500 and 40000 serviced during April 20121 and June 2015 in which a main board was replaced.

Distribution Pattern:

Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated