CareFusion 303, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2179-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

Product Classification:

Class I

Date Initiated: July 8, 2025

Date Posted: August 13, 2025

Recall Number: Z-2179-2025

Event ID: 97067

Reason for Recall:

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

Status: Ongoing

Product Quantity: 33,162,680 units total

Code Information:

BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046

Distribution Pattern:

US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey

Voluntary or Mandated:

Voluntary: Firm initiated