FDA Classifies Cardinal Health Instruction Update for Presource Kits as Class I Recall

What was announced

The U.S. Food and Drug Administration announced on November 9, 2026, that a safety correction issued by Cardinal Health is now classified as a Class I recall. This classification means using the device without following updated instructions could lead to serious injury or death.

Cardinal Health originally sent letters to affected customers on September 23. The notice affects certain Presource convenience kits, which contain packaged supplies for surgical or medical procedures. These kits include BD Alaris Pump Infusion Sets manufactured by BD and CareFusion 303, Inc. The action does not require facilities to return or remove the kits. Instead, Cardinal Health is instructing users to follow updated risk mitigation steps provided by BD.

What it means

Infusion pumps deliver precise amounts of fluids and medications to patients. Testing by BD revealed that specific infusion sets with restrictive parts, such as filters or check valves, do not deliver fluid as accurately as previously claimed. The problems occur most frequently at low flow rates under 1 mL/h and small bolus volumes at or below 5 mL. A bolus is a single, concentrated dose of medication given over a short period.

These inaccuracies may lead to under-infusion, over-infusion, or delayed warnings when tubing becomes blocked. High-risk patients receiving small medication doses, such as infants or critically ill individuals, face the highest risk of harm.

Healthcare providers using these kits should review the performance disclosures sent by BD. Recommendations include hanging solution containers no higher than 21 inches above the pump module, keeping clamps and vents open, and turning fluid flow off before clearing blockages. If the pump is not suitable for a patient's clinical needs, clinicians should switch to an alternative device, such as a syringe pump.

What the announcement does not tell us

The announcement does not state how many Presource kits or infusion sets are affected by this recall. It also does not specify which hospital departments or geographic regions received the impacted products.

While BD reported zero serious injuries or deaths associated with the issue as of August 19, 2026, the document does not clarify whether any adverse events were reported after that date. Finally, the notice does not mention a timeline for when BD or Cardinal Health might release redesigned infusion sets to fix the underlying performance issues permanently.