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# Smiths Medical Recall of Infusion Pumps is Class 1
- URL: https://www.fdaweb.com/smiths-medical-recall-of-infusion-pumps-is-class-1/
- Published: 2022-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:52:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152321

FDA has classified as Class 1 a Smiths Medical recall of its Medfusion 3500 and 4000 Syringe Infusion Pumps due to eight software malfunctions. The malfunctions may cause serious harm or death to patients from under- or over-infusion, or delays in medication delivery, according to a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-certain-medfusion-3500-and-4000-syringe-infusion-pumps-software-issues-may?ref=fdaweb.com). The devices are intended to deliver blood or blood products, lipids, drugs, antibiotics, enteral feedings and other therapeutic fluids through infusion tubing into a patient’s vein or through other cleared routes of administration. They are primarily used in the neonatal and pediatric populations or in operating rooms and intensive care units for adults.