BD Alaris Infusion System: Risks, Recalls & Lawsuits
BD Alaris Infusion Systems have faced FDA recalls and safety warnings due to potential malfunctions. Patients and hospitals have reported injuries, resulting in lawsuits alleging that BD sold defective devices without providing sufficient safety warnings.
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What Is the BD Alaris Infusion System?
Manufactured by Becton, Dickinson and Company (BD), the BD Alaris Infusion System is a comprehensive infusion system used in the U.S. It consists of multiple modules, including a pump, syringe and patient care assistant, that work together to provide infusions.
- Critical care
- Neonatal or pediatric intensive care units
- Oncology
- Outpatient
- Pain management
- Surgery
Unfortunately, there have been several recalls for different components of the BD Alaris Infusion System because of software and hardware issues. These problems have led to serious risks, including alarm delays and dosing errors, that have resulted in serious injuries and death.
Reported Risks and Side Effects of the BD Alaris Infusion System
BD has disclosed many mechanical and software failures associated with its Alaris Infusion System. These problems put patients at risk of dangerous and potentially fatal side effects.
- Alarm problems
- Delays in receiving therapy
- Device freezing
- Flow rate issues
- Infusion interruptions
- Outdated automated programming requests being disseminated
- Over or under-infusion of medication
- Unexpected delivery of medication
These risks caused some patients to experience side effects like dosing errors, serious injury and death.
FDA Warnings and Recalls
There have been numerous FDA recalls warning the public about BD Alaris Infusion System problems. Recalls have occurred as recently as July 2025.
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July 2025
A recall was initiated for the BD Alaris Pump Module Model, 8100 with Guardrails and Suite MX software versions because the pump module associated with compatible pump infusion sets might not work within the specified performance ranges for things like accuracy, flow rates and more.
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February 2025
BD initiated a recall about a software issue that can result in the delivery of an outdated automated programming request to the progressive care unit. The recall affected the BD Alaris Systems Manager and the REF 9601 Infusion Safety Management Software.
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December 2023
A recall was announced regarding labeling issues that may result in compatibility problems with Cardinal Health Monoject syringes. It pertained to the BD Alaris PCU, Alaris PCA Module and BD Alaris Syringe Module.
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February 2020
BD initiated a recall of five BD infusion pump issues that may impact patient safety due to software, system and use-related errors. This recall impacted PC Unit Model 8000, PC Unit Model 8015, Pump Module Model 8100, Syringe Module Model 8110 and PCA Module Model 8120.
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May 2019
A recall alert was initiated for the Alaris Pump Model 8100 Infusion Sets due to variations in the pumping segment’s wall thickness. This issue could have resulted in over-infusion or unexpected delivery of medication to patients.
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April 2019
BD issued a recall alert about the weakening of plastic in the Pump Module Model 8100. This may have led to problems with the bezel assembly that impacted the infusion process.
Why the BD Alaris Infusion System Faces Lawsuits
Some patients are suing BD, alleging that the Alaris Infusion System had serious defects and that the company didn’t adequately warn hospitals and patients about these risks. Plaintiffs also claim that BD committed corporate negligence because of delayed recalls and cover-ups.
Investors also filed BD Alaris lawsuits. This litigation focused on how BD:
- Misled investors about the risks of the device
- Didn’t alert investors that the FDA would block the sale of the system until the software was fixed and new clearance was granted
- Overstated its income by not accounting for the expense of fixing the device
Legal Rights for Patients and Hospitals
If you were harmed by BD Alaris Infusion System failures, you may qualify to file a product liability lawsuit. It’s important to have documentation of your hospital stay, complications and other medical records to verify that BD’s infusion system caused your injuries.
When you file a product liability lawsuit, you may be eligible to receive compensation for:
- Lost wages
- Pain and suffering
- Past and future medical costs
- Other financial losses related to your injuries
Your potential settlement amount will depend on the severity of your injuries and the other financial losses you incurred. If you’re unsure you qualify to file a lawsuit, you can get a free case review on Drugwatch. We can connect you with an experienced attorney who can tell you if you have a case.
While no litigation has been filed yet, hospitals and health systems that experienced financial losses from BD Alaris Infusion System recalls and equipment downtime may also be eligible to pursue legal action.
Recent Developments
The most recent litigation development about the BD Alaris Infusion System occurred in December 2024 when the U.S. Securities and Exchange Commission approved a settlement for a BD lawsuit. The company agreed to pay $175 million to settle claims that it misled investors about the safety and functionality of its Alaris infusion pumps.
“BD repeatedly painted a misleading picture of its Alaris infusion pump for investors and then doubled down by keeping them in the dark when the device’s issues came to a head with the FDA in late 2019,” stated Sanjay Wadhwa, Acting Director of the SEC’s Division of Enforcement. “Public companies have a fundamental duty to accurately disclose material business risks and should expect to be held accountable when they fall short in that regard.”
Additionally, the FDA published an update on September 15, 2025, about the July 2025 BD Alaris Pump Infusion Sets, expanding the recall to include 15 additional pumps. This was the second expansion of the July recall. The FDA warned that “the affected products have the potential to result in patient death or serious adverse events.”
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