Cardinal Health recalls

FDA classified this as a Class I recall of 11 Cardinal Health Presource PBDS kits, distributed in the US and Canada. Each kit contains BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100, and the infusion sets were recalled for performance issues. The kits are labeled with names such as anesthesia, cath lab, C-section, labor, and emergency kits. No injuries have been reported.

Serious·FDA·Nov 2, 202611 products

Cardinal Health Presource Packs contain Medtronic Microstream components that may be difficult to disconnect from a patient's breathing tube. Medtronic has updated the instructions for these kits to address this issue. The difficulty could delay treatment or cause unintended removal of the tube, potentially leading to serious breathing complications.

Moderate·FDA·Oct 14, 2026

Cardinal Health is recalling four Presource Pack surgical kits that contain Stryker StrykeFlow PS and AHTO tube sets. The handpieces on these tube sets may leak fluid during use, and the fluid can pool on the floor, creating a slip and fall risk. About 7,000 kits are included, and they were distributed nationwide, including in CA, IL, KY, MO, NC, NY, OH, and TX. No injuries have been reported.

Moderate·FDA·Oct 7, 20264 products

Cardinal Health is recalling 2 groups of Presource Convenience Kits, totaling about 26,983 kits, because the applicators inside may have an open or incomplete seal on their packaging. A possibly contaminated applicator could cause no harm, or could lead to a localized skin or soft tissue infection, and less commonly a more widespread infection. The kits were distributed nationwide, with the recall covering stock sent to FL, KY, MO, NC, OH, and TX, and no injuries have been reported.

Moderate·FDA·Sep 30, 20262 products

Cardinal Health is recalling 12 procedure kits that include BD Urinary Catheter Trays with CliniClean Pericare Wipes. The wipes may be contaminated with a lubricant used during manufacturing. If a contaminated wipe is used on a patient, it may cause localized skin irritation, redness, or mild inflammation. No injuries have been reported.

Moderate·FDA·Sep 9, 202612 products

Cardinal Health is recalling 8 Presource procedure kit product groups, sold under the Cardinal Health Presource Kits name, that contain MEDICOM Ritmed Neurological Sponges. The sponges had unexpected variability in endotoxin levels. The kits were distributed across the US and to Canada, and no injuries have been reported.

Moderate·FDA·Aug 19, 20268 products

Cardinal Health Monoject Tuberculin Syringes labeled as 1 mL Luer Lock (Catalog 1180100777) actually contain U-100 Insulin syringes inside the packages. This mislabeling could lead to incorrect dosing if the syringes are used without checking the actual contents. The affected lot numbers are 531164X and 531162X.

Moderate·FDA·Apr 8, 2026

Cardinal Health is updating instructions for multiple chest drainage unit models to clarify they are intended only for adults 18 years and older. When used on infants, these devices may not show proper bubbling or fluid movement, which can make it hard for clinicians to tell if the device is working correctly. This could delay or prevent needed treatment.

Moderate·FDA·Feb 4, 2026

Cardinal Health ChemoPlus protective gowns and sleeves have been mislabeled with a five-year shelf life when the actual shelf life is three years. The affected gowns may be used past their true expiration date if the incorrect label is relied upon. No injuries have been reported.

Moderate·FDA·Dec 17, 2025