Alaris Infusion Pump Recall Lawsuit | 2025 Latest Updates

Alaris Infusion Pump Recall Lawsuit Overview

The Alaris Infusion Pump lawsuits center on allegations of device malfunctions and defects that have led to serious patient injuries. Becton, Dickinson and Company (BD) issued a nationwide recall of multiple Alaris infusion pump models due to potentially defective hardware systems. The FDA has designated three of these situations as Class I recalls, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death [1].

Latest Alaris Infusion Pump Lawsuit Updates

• March 20, 2025 –The FDA has posted a software correction notice for Alaris pumps by BD, spotlighting technical flaws that have contributed to safety risks now at the center of ongoing lawsuits [2].
• December 16, 2024 – BD has agreed to an $85 million SEC settlement over claims it misled investors about known Alaris pump defects, reinforcing legal claims of corporate negligence tied to the device’s safety record.
• December 26, 2023 – Following years of safety issues and regulatory scrutiny, BD has reached an $85 million settlement tied to Alaris infusion pump defect disclosures—fueling parallel lawsuits from injured patients and investors.
• December 19, 2023 – The FDA issued a Class I recall for Alaris infusion pumps due to dangerous compatibility issues—further evidence cited in lawsuits over BD’s failure to ensure safe use of its medical devices.

FDA Reports and Statistics

According to the U.S. Food & Drug Administration, this recall affects multiple Alaris System models including the PC Unit Models 8000 and 8015, Pump Module Model 8100, Syringe Module Model 8110, PCA Module Model 8120, EtCO2 Module Model 8300, SpO2 Module Models 8210 and 8220, and Auto ID Module Model 8600.

The FDA has classified three of the recall situations as Class I, which is the most serious type of recall. This classification 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, which means “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

Defective Alaris infusion pumps can lead to a range of serious health complications due to medication delivery errors:

• Over-infusion or Under-infusion: Incorrect dosing of critical medications
• Delayed or Interrupted Therapy: Failure to deliver necessary medications at prescribed times
• System Errors: Device malfunctions leading to treatment delays or incorrect medication administration
• Air Embolism: Air entering the bloodstream causing potentially fatal complications

Do You Qualify for an Alaris Infusion Pump Lawsuit?

You may qualify for an Alaris Infusion Pump lawsuit if:

• You or a loved one received medication through an affected Alaris infusion pump model
• You experienced serious complications or injuries as a result of 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

• Medical records documenting your injury
• Documentation of the specific Alaris pump model used in your treatment
• Hospital records indicating pump malfunction or error
• Expert testimony linking the device’s defects to your health issues

Damages You Can Recover

• Medical expenses for treatments, surgeries, and ongoing care
• Lost wages and diminished earning capacity
• Pain and suffering resulting from injuries
• Punitive damages in cases of gross negligence

Alaris Infusion Pump Recall Information

The recall for Alaris infusion pumps addressing hardware defects began on June 30, 2020, with an addendum issued on August 20, 2020. The recall affects multiple Alaris System models with the following defective hardware issues:

• Damaged Inter-Unit Interface (IUI) Connectors (Class I)
• Broken elements on Alaris™ Pump Module platen (Class I)
• Improperly secured PC unit battery (Class I)
• Dim LED segment(s) on Alaris™ modules (Class II)

On July 21, 2023, the FDA granted 510(k) clearance to the updated BD Alaris System, allowing BD to resume distribution and address older recalled devices through remediation or replacement.

Statute of Limitations for Alaris Infusion Pump Lawsuits

The timeframe to file a lawsuit related to Alaris Infusion Pump injuries, known as the statute of limitations, varies by state. It’s crucial to consult with an attorney promptly to ensure you file within the legal time limits applicable to your case. Depending on your state, this period typically ranges from 1-3 years from the date of injury or discovery of injury.

Related Articles:

• Medtronic SynchroMed Infusion Pump Lawsuit
• HawkOne Directional Atherectomy System Litigation
• Endotracheal Tube Lawsuit

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

FAQs

1. How do Alaris pumps work?

Alaris infusion pumps come with a point of care unit (PCU) which can be customized with up to 4 modules. These modules are connected to tubes and bags of medicine or other fluids. The modules work together with the PCU to perform various functions.

2. What is the new technology in Alaris Infusion Pumps?

A programmed infusion pump, or smart pump, comprises a drug library which is called a dosage error-reduction system. Smart pumps administer IV fluids and drugs while following pre-defined parameters, such as drug concentration and dosage.

3. 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.

4. How long do I have to file a lawsuit for issues with the Alaris Infusion Pump?

The time frame varies by state. It’s important to consult with an attorney promptly to ensure you file within the legal time limits applicable to your case.

5. What evidence is needed to support my Alaris Infusion Pump lawsuit?

Key evidence includes medical records documenting the injury, the infusion pump model information, maintenance records, and expert testimony linking the device’s defects to your health issues.

6. Can I file a lawsuit if the Alaris Infusion Pump no longer has warranty coverage?

Yes, you can still file a lawsuit if the infusion pump no longer has warranty coverage, especially if the issues are related to inherent defects or safety failures.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for injuries caused by defective Alaris infusion pumps. Most states have a statute of limitations of only 1-3 years from the date of injury, after which you may lose your right to seek compensation.At Schmidt & Clark, LLP, we offer:

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

Do I Have an Alaris Infusion Pump Recall Lawsuit?

The Products Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Alaris Infusion Pump Recall Lawsuits. We are handling individual litigation nationwide and are currently accepting new injury and death cases in all 50 states.

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

Reference:

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

[2] https://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-software-correction-becton-dickinson-and-company-bd-issues-correction-bd-alaris