Alaris Pump Infusion Set Recall Issued Due to Medication Delivery Errors, Alarm Failures

More than 33 million Alaris infusion pump sets are part of a Class 1 medical device recall, due to a risk that malfunctions could cause severe injury or death.

Certain Alaris infusion pumps have been found to malfunction when used with specific tubing sets, potentially causing incorrect medication delivery, delayed occlusion warnings or inaccurate dosing once a blockage is resolved.

As a result, the U.S. Food and Drug Administration (FDA) announced an Alaris pump infusion set recall on August 6, classifying it as a Class I recall, which is the most serious designation the agency can apply, suggesting that continued use of the product poses a risk of severe injury or death.

Alaris pump infusion sets are the tubes and components used with Alaris pumps to deliver medication or fluids directly into a patient’s bloodstream. These systems help regulate flow and ensure accurate dosing, and are widely used in hospitals for intravenous treatments. 

However, if an infusion pump malfunctions, it may deliver the wrong amount of medication or fluids, potentially causing serious harm or even death.

The recall includes more than 33 million Alaris pump infusion sets made by Becton Dickinson (BD), with the full list of affected pumps in the recall notice. The company is currently investigating the cause of the problem.

According to the company, the affected devices may still be used if all safety steps outlined in the notification are carefully followed. Attachment B of the recall notice includes updated performance data to help providers compare the revised guidance with existing user manuals.

Healthcare facilities are instructed to post the customer notification near affected products and distribute the information throughout their networks to ensure all relevant personnel are informed. Clinical teams should also review ongoing procedures to confirm whether any recalled infusion sets are in active use.

All customers, regardless of whether they currently have affected products in their inventory, are required to complete and return a Customer Response Form. Forms should be submitted by fax to 312-949-0068 or by email to BDRC49@bd.com. Any issues with the products can be reported directly to BD at productcomplaints@bd.com.

For more information, customers can contact BD Technical Support at 888-812-3229, Monday to Friday from 6 a.m. to 5 p.m. PT, or email DL-US-INF-TechSupport@bd.com.

Prior Alaris Infusion Pump Recall

In 2024, BD also recalled certain Alaris infusion pumps due to similar safety risks.

The Alaris syringe and patient-controlled analgesia (PCA) pump recall was initiated after reports of at least 13 injuries caused by incompatibility issues, leading to medication dosing errors, delayed blockage alarms and other performance problems.

The prior recall affected approximately 220,120 Alaris syringes and PCA modules, as well as approximately 867,362 PCU pain pump modules distributed between June 19, 2004 and September 22, 2023.

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