Alaris Infusion Pump Recall Lawsuit | 2025 Latest Updates

Alaris Infusion Pump Recall Lawsuit Overview

The Alaris infusion pump recall lawsuits address serious malfunctions in these widely used medical devices, which deliver medications, fluids, blood, and blood products to patients. Primary allegations against Becton, Dickinson and Company (BD) include defective inter-unit interface (IUI) connectors, broken hardware elements (e.g., hinge posts, bezel posts), improperly secured batteries, dim LED displays, unresponsive or stuck keypads, and software errors (e.g., inaccurate concentration programming, keep vein open [KVO] alarm misprioritization), leading to medication errors, infusion delays, or interruptions.Lawsuits allege that BD failed to adequately design, test, or warn about these defects, resulting in serious injuries, comas, or death. The FDA designated at least six situations as Class I recalls between 2020 and 2025, indicating a reasonable probability of serious adverse health consequences or death.

Latest Alaris Infusion Pump Recall Lawsuit Updates

April 15, 2025

– According to Drugwatch, lawsuits against BD allege that the company failed to adequately address software errors in its Alaris infusion pumps, resulting in patient injuries and safety risks [1].

March 20, 2025 – The FDA issued a Class I recall for BD’s Alaris infusion pumps due to software issues that could delay or interrupt medication delivery—posing serious risks to patients.

December 16, 2024 – The SEC fined BD $12 million for misleading investors about unresolved safety concerns with its Alaris infusion pumps, a key element also cited in consumer lawsuits.

December 19, 2023

– According to the FDA, BD’s Alaris pumps were recalled due to compatibility issues that could lead to inaccurate medication delivery—a key issue in ongoing lawsuits.

FDA Reports and Statistics

According to the U.S. Food & Drug Administration (FDA), this recall affects [2]:

• Alaris™ System PC Unit Model 8000
• Alaris™ System PC Unit Model 8015
• Alaris™ Pump Module Model 8100
• Alaris™ Syringe Module Model 8110
• Alaris™ PCA Module Model 8120
• Alaris™ EtCO2 Module Model 8300
• Alaris™ SpO2 Module Model 8210 and Model 8220
• Alaris™ Auto ID Module Model 8600

Three of these situations have been designated as Class I recalls by the FDA, which means “there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.” One situation was designated as a Class II recall, meaning “use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Alaris Infusion Pump Injuries & Side Effects

Alaris Infusion Pump malfunctions can lead to various serious injuries and complications due to improper medication dosing.

• Medication Errors: Incorrect dosing of medications potentially leading to under-treatment or overdose
• Device Failures: Sudden cessation of critical medication delivery
• Alarm Failures: Failure to alert healthcare providers to dangerous conditions
• System Errors: Software or hardware malfunctions causing unpredictable device behavior

Do You Qualify for an Alaris Infusion Pump Recall Lawsuit?

You may qualify for an Alaris Infusion Pump lawsuit if:

• You or a loved one was treated with an Alaris Infusion Pump that was later subject to recall
• You experienced complications or injuries related to pump malfunction
• The injuries required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to the Alaris Infusion Pump

Evidence Required for an Alaris Infusion Pump Lawsuit

To build a strong case, you will need:

• Medical records documenting the use of an Alaris Infusion Pump
• Documentation of injuries or complications that occurred
• Medical expert testimony linking the device malfunction to your injuries
• Proof that the specific pump used was among the recalled models

Damages You Can Recover

Victims of Alaris Infusion Pump malfunctions may be entitled to compensation for:

• Medical expenses, both current and future
• Lost wages and diminished earning capacity
• Pain and suffering
• Emotional distress
• In cases of death, wrongful death damages for surviving family members

Alaris Infusion Pump Recall Information

The Alaris Infusion Pump recall began on August 20, 2020, affecting multiple models with potentially defective hardware systems:

• Damaged Inter-Unit Interface (IUI) Connectors
• Broken elements on Alaris™ Pump Module platen
• Improperly secured PC unit Battery
• Dim LED Segment(s) on the Alaris™ modules

On July 21, 2023, the FDA granted 510(k) clearance to the updated Alaris infusion pump, allowing BD to resume distribution while addressing previously recalled devices.

Statute of Limitations for Alaris Infusion Pump Lawsuits

The statute of limitations for filing an Alaris Infusion Pump lawsuit varies by state, typically ranging from 1-3 years from the date of injury or from when you reasonably discovered the connection between your injury and the defective device. It’s crucial to consult with an attorney promptly to ensure your legal rights are protected before time limits expire.

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See all related medical device lawsuits our attorneys covered so far.

FAQs

1. What Is the Alaris Infusion Pump Recall About?

The Alaris infusion pump recall addresses multiple models reported to malfunction, potentially leading to medication errors and patient harm. The recall affects various hardware issues including damaged connectors, broken pump module elements, unsecured batteries, and display problems.

2. What Are the Potential Risks Associated With the Malfunction of the Alaris Infusion Pump?

The potential risks include improper dosing of medications (either under-dosing or overdosing), sudden cessation of critical medication delivery, and failure to alert healthcare providers to dangerous conditions, all of which can lead to serious health complications or death.

3. Who Can File an Alaris Infusion Pump Lawsuit?

Patients who experienced harm due to a malfunctioning Alaris Infusion Pump, or family members of patients who died due to such malfunctions, can file a lawsuit. Healthcare facilities that have suffered economic damages may also have legal claims.

4. What Are the Three Major Problems With Infusion Pumps?

The three major problems with infusion pumps are software defects, user interface issues, and mechanical or electrical failures. Software defects can cause pumps to either fail to activate alarms when issues arise or trigger false alarms. User interface issues can lead to confusion or errors in operation, while mechanical or electrical failures can result in the pump not working properly, potentially leading to serious health risks.

5. What Happened to Alaris Pumps?

Becton Dickinson (BD)/Carefusion 303 recalled multiple Alaris infusion pump models due to various hardware defects. The FDA classified several of these issues as Class I recalls, indicating potential for serious injury or death. After three years, BD received FDA clearance for updated models in July 2023.

6. How Do Alaris Pumps Work?

Alaris infusion pumps feature a point of care unit (PCU) customizable with up to 4 modules. These modules connect to tubes and bags of medicine or other fluids, working together with the PCU to administer controlled amounts of medication or fluids to patients.

7. What is the New Technology of Alaris Infusion Pumps?

The updated Alaris infusion pumps function as “smart pumps” with a drug library called a dosage error-reduction system. These smart pumps administer IV fluids and drugs following pre-defined parameters, such as drug concentration and dosage, to improve safety.

8. Are Alaris Infusion Pumps Approved by the FDA?

Yes, the FDA granted 510(k) clearance to the updated Alaris infusion pump on July 21, 2023, allowing BD to resume distribution while remediating or replacing older recalled devices.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for injuries caused by defective Alaris Infusion Pumps. In most states, you have only 1-3 years from the date of injury to file a claim. Don’t delay in seeking legal advice.

The Products Liability Litigation Group at Schmidt & Clark, LLP offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees
• Payment only if we win your case

If you or a loved one was injured by a recalled Alaris infusion pump, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

References:

[1] https://www.drugwatch.com/bd-alaris-systems/lawsuits/ 

[2] https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-previously-disclosed-recall-bd-alaris-system-hardware