smiths medical Medfusion Model 4000 syringe pump

Recall Insight

This FDA Devices action (record #Z-0864-2024) was formally reported on February 7, 2024, with the manufacturer initiating the action on December 19, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Smiths Medical ASD Inc. is listed as the recalling firm, operating out of Minneapolis, MN. Federal records indicate 60146 pumps units are affected.

The documented reason for this recall is: Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administ… Distribution data in the federal record shows the product reached: US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore, Saudi Arabia, Lebanon, and Malaysia. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.