BD Issues Correction for Alaris Pumps After Drop-Related Injuries

BD has issued a Class I correction for its Alaris pump modules following two serious injury reports linked to dropped or severely jarred devices. The FDA classified the action as Class I due to the risk of serious injury or death.

In an October 17 letter to users, BD advised healthcare providers to immediately remove any dropped or jarred pumps from use. Devices should only be reused after thorough inspection and testing by qualified personnel. Damage to the bezel assembly, which supports critical pumping components, can cause under- or over-infusion, unregulated flow, or calibration failures, potentially resulting in severe patient harm.

BD previously faced regulatory scrutiny, paying $175 million in 2024 for misleading investors on Alaris issues and recalling pumps with variable performance in September 2025. Despite these problems, BD’s updated Alaris system, cleared by the FDA in 2023, continues strong installations, though legacy devices remain a safety concern.

08-12-2025