BD (Becton, Dickinson and Company), a prominent global medical technology firm, has issued an update on its voluntary recall concerning certain Alaris and BD Alaris Pump Modules. These modules may have been serviced with bezel kit assemblies that were previously recalled.
The recall pertains to bezel kit assemblies manufactured between April 2011 and June 2017, which were initially recalled in 2019. BD emphasized that these assemblies should not be used for servicing the Alaris and BD Alaris Pump Module.
BD became aware of the issue through customer complaints regarding the use of affected bezel kit assemblies by customers or third parties. The assemblies in question were made with a type of plastic material that degrades over time, potentially causing serious malfunctions such as free flow, over infusion, under infusion, or interruption of infusion. There have been reports linking this issue to serious injuries and patient deaths.
Previously, the field action targeted bezel kit assemblies manufactured with FR-110 bezels used for servicing Alaris and BD Alaris Pump Modules (8100). However, since pump modules not originally built with these bezels might have been serviced using them, this recall includes all Alaris and BD Alaris Pump Modules.
BD advises customers to dispose of any remaining affected bezel kit assemblies. They should also verify if their pump modules have been serviced with these parts and conduct visual inspections where necessary. If affected bezels are identified, pumps should be removed from service immediately, and customers should contact BD for further guidance.
Information about the recall is available on BD's website or by calling 1-888-562-6018. Notifications will be sent to all customers starting July 15, 2025.
Complaints related to this product can be reported to the BD Complaint Center at 1-844-823-5433 during business hours or via email at productcomplaints@bd.com.
Adverse reactions or events should be reported to the FDA's MedWatch Program online at www.fda.gov/medwatch/report.htm or by calling 1-800-FDA-1088. Reports can also be submitted via regular mail using forms available at www.fda.gov/MedWatch/getforms.htm.
For more information about BD's efforts in advancing health care technology globally, visit bd.com or follow them on LinkedIn, X (formerly Twitter), or Instagram.
Media inquiries can be directed to Troy Kirkpatrick at troy.kirkpatrick@bd.com. Investors can reach out to Adam Reiffe at adam.reiffe@bd.com.
