FDA Issues Urgent Alert: High-Risk Issue with Baxter Infusion Pumps

The US Food and Drug Administration (FDA) has issued an early alert regarding a potentially high-risk issue with Baxter Sigma Spectrum and Spectrum IQ infusion pumps. Baxter is recalling affected pumps due to missing motor mounting screws, which could lead to insufficient or excessive therapy, interruptions, or delays, resulting in serious health consequences. The FDA has requested a user-level recall of affected products. This alert is part of the FDA's pilot program to expedite communication about high-risk medical device recalls. Baxter has faced multiple FDA alerts in recent years, including recalls of its AK 98 hemodialysis machines and Life2000 ventilators in 2024.