October 20, 2026 — SNN Newsroom. The Food and Drug Administration has issued an early safety alert about Cardinal Health Presource medical procedure kits that may contain recalled BD Alaris pump infusion sets. The agency says the affected infusion sets can malfunction and cause too much, too little, or no fluid or medication to be delivered.
The FDA says Cardinal Health sent affected customers a letter September 24 directing them to locate and quarantine affected kits, alert clinicians and place conspicuous warning labels on kits. The labels instruct staff to remove and discard the recalled BD Alaris pump infusion components. Distributors were advised to inform customers to whom affected kits had been supplied.
Because an infusion pump administers liquids and medications into patients, unexpected delivery can create serious risks, particularly for infants, children and critically ill patients, the agency said. This alert concerns specified Presource kits containing affected components, not all Cardinal Health products.
The FDA described this notice as an early alert while it reviews information about a potentially high-risk device issue; the agency has not characterized this particular alert as a newly confirmed recall of every Presource kit. The underlying BD Alaris infusion sets were subject to a separate recall. As of August 19, BD had reported no serious injuries or deaths associated with the underlying issue, according to the FDA’s alert.
Healthcare facilities should consult the FDA’s device-specific notice and affected-product information for the full corrective steps. Cardinal Health lists a contact number for affected U.S. customers: (800) 292-9332.
Source: U.S. Food and Drug Administration early alert published October 20, 2026.
