What Is Being Recalled?

The recall involves certain BD Alaris Pump Infusion Sets used with the BD Alaris Pump Module Model 8100, including systems running BD Alaris with Guardrails Suite MX through version 12.6.

BD continued testing the infusion sets and found that previously reported performance had been overestimated. According to the FDA, some sets with restrictive components or designs, including filters, check valves, Y-sites, closed male luer components, and microbore tubing, can perform significantly worse than previously disclosed.

The deviations occur most commonly at programmable flow rates below 1 mL per hour and with bolus volumes of 5 mL or less.

The FDA recall database lists 94,230,757 units in commerce and currently identifies device design as the cause of the recall. FDA notes that recall-cause determinations can be modified until a recall is terminated. The recall remains open.

How Can a BD Alaris Infusion Set Deliver the Wrong Amount?

An infusion pump should deliver fluids and medications at the programmed rate and volume. The current BD Alaris recall identifies several ways that actual delivery may differ from what clinicians expect.

The FDA identifies risks involving:

• Under-infusion: The patient receives less medication or fluid than intended.
• Over-infusion: The patient receives more than intended, potentially functioning as a medication overdose when a drug is being infused.
• Inaccurate bolus dosing: A programmed bolus may deliver an incorrect amount.
• Delayed occlusion alarms: A blockage may exist longer before the pump alerts clinicians.
• Post-occlusion bolus problems: Pressure that builds up during an occlusion can lead to unintended medication or fluid delivery when the blockage is relieved.

These problems may be difficult for clinicians to recognize as the reason a patient’s condition changes. That makes the recall especially important when an unexplained deterioration occurs during an infusion.

Why Low-Volume Infusions Can Be Especially Dangerous

The FDA specifically identifies neonates, pediatric patients, and critically ill patients as higher-risk populations because they are more likely to receive medications at very low rates or in small volumes.

Those medications may include antiarrhythmics or drugs used to support blood pressure. When treatment requires precise delivery, even a small difference between the programmed dose and the amount actually delivered can have serious consequences.

The FDA states that the identified performance problems could result in serious adverse events or death in vulnerable patients. However, the agency’s current communication also states that as of August 19, 2026, BD had not reported serious injuries or deaths associated with this specific issue.

That distinction matters. A Class I recall identifies the potential for severe harm. It does not establish that every recalled infusion set malfunctioned or that the recall caused a particular patient’s injury.

What Are Hospitals Being Told to Do?

FDA and BD have instructed healthcare facilities to identify and discard discontinued Alaris Pump Sets covered by the corrective action and use clinically appropriate alternatives.

Where alternatives are limited, the FDA says facilities should prioritize available sets for critical-care, neonatal, infant, and pediatric patients. Depending on the clinical situation, providers may also need to consider the BD Alaris Syringe Module or another syringe pump.

If no alternative is available, FDA guidance calls for enhanced clinical monitoring and specific risk-mitigation measures, including pump setup, tubing placement, pressure settings, and occlusion management.

Patients and families should not attempt to adjust hospital infusion equipment themselves. Anyone concerned that an affected device may have been involved in a serious injury should raise the issue with the treating medical team and request information identifying the pump and infusion set used.

When an Infusion Injury May Involve Product Liability, Medical Negligence, or Both

A serious infusion injury can require investigation of more than one potential failure.

FDA’s recall database currently lists device design as the cause of the recall. When evidence links an injury to a defective infusion set or another medication-delivery product, the circumstances may support an investigation into a medical device product-liability claim. Depending on the evidence and applicable law, the investigation may address design defects, warnings, instructions, testing, and the manufacturer’s response to known performance problems.

Hospitals and healthcare providers present a separate question. A provider does not become negligent simply because it used a product that was later recalled. But potential medication-error and medical-negligence issues may require review if staff failed to follow an active recall or safety communication, continued using a discontinued set, missed an important alarm, failed to monitor a high-risk patient, or failed to respond appropriately when the patient’s condition changed.

For that reason, catastrophic infusion cases may require analysis of both the product and the care surrounding its use.

What Evidence Matters After a Suspected BD Alaris Infusion Injury?

A medication-delivery investigation requires more than the patient’s discharge records. Important evidence may include:

• The specific BD Alaris pump and infusion-set model
• Catalog, lot, serial, or UDI information
• The medication or fluid being infused
• Programmed infusion rate and bolus settings
• Pump history and event logs
• Alarm and occlusion data
• Medication administration records
• Pharmacy dispensing and preparation records
• Nursing flow sheets and monitoring records
• Vital signs and clinical changes during the infusion
• Hospital recall notices and internal safety communications
• The actual infusion set and associated components, when they remain available

Patients and families should consider requesting that relevant equipment, electronic data, and records be preserved after a catastrophic event.

McEldrew Purtell handles claims involving infusion pumps and medication-delivery devices where product performance, medication administration, alarms, monitoring, or other safety failures may have contributed to serious harm.

Does the BD Alaris Recall Prove a Legal Claim?

No. A recall does not establish that a specific infusion set malfunctioned or caused an injury.

The recall, however, can identify a documented failure mode that warrants investigation. A legal and medical review must connect the affected product, the delivery problem, the medication involved, the patient’s clinical course, and the resulting injury.

That analysis becomes particularly important when a patient deteriorated unexpectedly while receiving a low-rate infusion, experienced a suspected overdose or underdose, or suffered serious injury after an infusion pump appeared to be operating normally.

Questions After a Serious Infusion Injury

When an infusion system delivers too much or too little medication, determining what happened may require the pump data, medical records, pharmacy records, product identification, recall history, and expert review.

If you or a loved one suffered a catastrophic injury after a suspected BD Alaris infusion failure, contact McEldrew Purtell for a free consultation. The firm can evaluate the circumstances and determine whether a defective medical device, medication-delivery failure, medical negligence, or a combination of factors requires further investigation.