The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ issue with certain Baxter Sigma Spectrum and Spectrum IQ infusion pumps.

The agency’s notice highlights that Baxter has issued a letter to affected customers, recommending its Sigma Spectrum Infusion System V6 platform and Spectrum IQ Infusion System with Dose IQ Safety Software either be removed from sale or no longer used.

Baxter said the Spectrum infusion pumps are being recalled due to the potential of missing motor mounting screws. The issue, which is thought to have arisen during the servicing process, may lead to ‘insufficient or excessive’ therapy, therapy interruption, or delays in therapy, the company said, all of which can result in serious adverse health consequences.

One serious injury related to the issue has been reported so far, with Baxter requesting that all affected pumps, which are intended to be used for the controlled administration of fluids such as medicine, blood, and blood products, be recalled for inspection and reservicing as applicable.

The FDA has requested that dealers, wholesalers, distributor/resellers or original equipment manufacturers that distributed any affected product to other facilities conduct a user-level recall of the affected product. The agency noted that it is currently reviewing information about the potentially high-risk issue and will keep the public informed as significant new information becomes available.

The early alert is part of the FDA Center for Devices and Radiological Health’s (CDRH) pilot centred on improving the timeliness of communications to the public around corrective actions being taken by companies with devices believed to be high-risk recalls. Initiated in November 2024, the pilot is designed to provide early alerts on potentially high-risk device removals or corrections related to devices spanning medical fields, including cardiovascular, gastrorenal, general hospital, obstetrics and gynaecology, and urology.

Baxter has faced its share of recall issues lately. Last year, the company issued a correction for its AK 98 haemodialysis machines, with the FDA classifying the recall as Class I, the agency’s most serious recall designation meaning that continued use of the products, without actions being taken, could cause serious injury or death.

Also in 2024, Baxter’s Life2000 ventilator devices, of which there are more than 2,500 currently in commerce, according to the FDA’s recall database, were hit with a Class I recall by the FDA. The company acquired the Life2000 ventilation system, a portable ventilator for patients who have chronic respiratory failure or other breathing-associated medical issues, from Hillrom for $10.5bn in 2021.