BD has expanded its Class I voluntary recall of certain BD Alaris Pump Module model 8100 infusion sets. The recall, which began in the United States on July 8, 2025 and was previously expanded on July 17, now includes 15 additional pump infusion sets that had been discontinued but may still be in use based on their expiration dates.
The company identified the issue through internal testing and has not received any complaints related to the problem so far. According to BD, the affected products could result in patient death or serious adverse events, with a higher risk for vulnerable groups such as neonates and critically ill patients. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall.
Variations in pump performance compared to what is described in the user manual could affect infusion delivery. This includes possible inaccuracies in flow rate and loading bolus dose (either over- or under-infusion), delays in upstream and downstream occlusion alarms, and excessive post-occlusion bolus volume. These issues may impact how accurately medication or fluids are delivered, depending on both the type of substance being infused and each patient's condition.
The deviations are linked to design features of these pump infusion sets, including filters and other components within the line. The recalled products were distributed across the United States—including Guam and Puerto Rico—as well as Canada, Belgium, and South Africa.
On September 11, 2025, BD sent an update to customers outlining new corrective actions along with recommendations for alternative compatible BD Alaris Pump infusion sets when appropriate. Customers also received a list of the additional impacted products included in this latest expansion of the recall.
Information about this recall can be found on BD's website or by calling BD at 1-888-562-6018. Customers are encouraged to report any product-related complaints to the BD Complaint Center at 1-844-823-5433 or by emailing productcomplaints@bd.com.
Adverse reactions or events involving these products should also be reported to the FDA's MedWatch Program via their online portal (www.fda.gov/medwatch/report.htm), by phone at 1-800-FDA-1088, or by mail using forms available from www.fda.gov/MedWatch/getforms.htm.
BD describes itself as one of the largest global medical technology companies focused on improving medical discovery, diagnostics, and care delivery worldwide. The company employs more than 70,000 people globally and operates in nearly every country.
