CareFusion recalls

BD ChloraPrep Clear, a sterile skin antiseptic solution used before medical procedures, may have open or incomplete seals on individual applicator packaging. This could allow contamination of the sterile product. The issue affects multiple lot numbers distributed nationwide.

Moderate·FDA·Jul 22, 2026

CareFusion is recalling 10 antiseptic skin prep products sold as BD ChloraPrep (Hi-Lite Orange, Clear and Scrub Teal), BD PurPrep, and ChloraPrep FREPP. Applicators that were meant to be sterilized before use were instead shipped to customers outside the intended distribution channel, so they may not be sterile. No injuries have been reported.

Moderate·FDA·Jul 8, 202610 products

CareFusion is recalling four sizes of BD ChloraPrep Clear and BD ChloraPrep FREPP Clear skin antiseptic applicators because wrinkles in the paper lid may break the seal, so the products may not stay sterile. No injuries have been reported. The products were distributed nationwide in the U.S. and to other countries.

Moderate·FDA·Jul 1, 20264 products

The labeling on BD Alaris System with Guardrails Suite MX does not specify which version of Transport Layer Security (TLS) must be enabled on hospital networks for secure Wi-Fi communication with Point-of-Care Units. This could create confusion during setup and potentially leave devices with inadequate security settings.

Moderate·FDA·Apr 1, 2026

Some BD Alaris Pump Module 8100 infusion pumps have a software date/time issue related to daylight saving time that may prevent them from connecting to hospital networks. This affects only the network connectivity function; the pump's ability to deliver medication is not impacted. The issue involves 189 devices distributed in Arizona, Indiana, Ohio, and Virginia.

Moderate·FDA·Feb 4, 2026

A software issue in certain BD Pyxis ES Enterprise Server systems may prevent timely updates of patient, medication, and related information from reaching the dispensing cabinets. This could delay access to critical data in healthcare settings. BD and the FDA are working to address the problem.

Moderate·FDA·Jan 14, 2026

CareFusion 213, LLC is recalling BD ChloraPrep Triple Swabsticks (a skin antiseptic swab) because the manufacturer cannot confirm the product was properly sterilized. The affected lot (#5086623, expiring 3/31/2028) was distributed nationwide. No injuries have been reported.

Moderate·FDA·Jan 7, 2026

BD Pyxis automated medication dispensing cabinets used in hospitals and pharmacies received a firmware update that caused certain drawers to fail. When a drawer fails, staff may have difficulty accessing or restocking medications, which could delay patient care.

Moderate·FDA·Dec 31, 2025

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

FDA·Nov 26, 2025