Table of contents
- Latest Alaris Pump Recall Lawsuit Updates
- October 5, 2026: FDA Updates Alaris Infusion Set Recall
- August 19, 2026: BD Sends Updated Infusion Set Letter
- November 28, 2025: FDA Posts Alert on Dropped Alaris Pumps
- November 20, 2025: FDA Database Lists Dropped Pump Recall
- October 17, 2025: BD Tells Customers to Inspect Dropped Pumps
- October 8, 2025: FDA Database Lists Infusion Set Recall
- September 29, 2025: FDA Classifies Infusion Set Issue as Class I
- September 12, 2025: BD Expands Alaris Recall by 15 Infusion Sets
- July 15, 2025: BD Recalls Pump Modules Serviced with Bezel Kits
- December 16, 2024: BD Pays $175 Million SEC Penalty
- December 26, 2023: BD Files $85 Million Investor Settlement
- December 21, 2023: Investors Seek Approval of $85 Million Deal
- August 11, 2022: Judge Allows Part of Investor Suit to Proceed
- February 27, 2020: Investors File Class Action Against BD
- What Is the Alaris Pump?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- How Do I Report an Alaris Pump Problem?
- What Does the Research Say About Alaris Pump Software Flaws?
- Does an Alaris Pump Recall Prove BD Is Liable?
- Is the Alaris Bezel Kit Recall a Global Recall?
BD Alaris pumps and infusion sets are under FDA Class I recalls for risks of over-infusion, under-infusion, free flow and interrupted infusion. The FDA last updated its infusion set notice on October 5, 2026.
No patient injury lawsuit or MDL names the Alaris pump. An investor class action settled for $85 million. BD paid a $175 million SEC civil penalty, but neither payment went to patients.
If you think a pump harmed you or a family member, tell your care team and report the problem to the FDA.
Latest Alaris Pump Recall Lawsuit Updates
October 5, 2026: FDA Updates Alaris Infusion Set Recall
The FDA updated its Class I communication on BD Alaris Pump infusion sets, adding affected products and new performance data [1]. BD testing found earlier performance claims were overestimated.
Some sets perform worse than BD first disclosed, according to the FDA notice. The deviations most commonly occur at low programmable rates under 1 mL/h and at or under 5 mL of bolus volume.
August 19, 2026: BD Sends Updated Infusion Set Letter
BD and CareFusion sent affected customers an updated letter on worse performance of infusion sets used with the Alaris Pump Module 8100. The letter also covered the discontinuation of certain sets, as the FDA reported.
November 28, 2025: FDA Posts Alert on Dropped Alaris Pumps
The FDA posted a Class I correction alert, Medtech Dive reported [2]. BD also updated its use instructions for the Alaris Pump Module.
BD said drops or severe jarring may damage the pump module bezel assembly. The damage can cause under-infusion, over-infusion, unregulated flow, or failure of the module to calibrate.
November 20, 2025: FDA Database Lists Dropped Pump Recall
The FDA recall database posted the dropped-or-jarred pump correction as Class 1 recall Z-0430-2026 with CareFusion 303, Inc. named as the recalling firm [3].
October 17, 2025: BD Tells Customers to Inspect Dropped Pumps
BD sent all affected customers a letter recommending that Alaris Pump Modules that were dropped or severely jarred be taken out of use. The letter said biomedical engineering should inspect these modules before reuse.
October 8, 2025: FDA Database Lists Infusion Set Recall
The FDA recall database posted the infusion set recall as Class 1 recall Z-0035-2026 for CareFusion 303, Inc. [4]. The record covers the BD Alaris Pump infusion set issue.
September 29, 2025: FDA Classifies Infusion Set Issue as Class I
The FDA updated its notice on Alaris infusion sets with additional affected products and recommended actions. The FDA also classified the issue as a Class I recall.
September 12, 2025: BD Expands Alaris Recall by 15 Infusion Sets
BD expanded its voluntary recall of the Alaris Pump Module 8100 and compatible infusion sets by 15 additional infusion sets, MassDevice reported [5]. The expansion came with new corrective actions and risk information.
July 15, 2025: BD Recalls Pump Modules Serviced with Bezel Kits
BD issued a voluntary recall of Alaris pump modules that may have been serviced with previously recalled bezel kit assemblies. The kits were made between April 2011 and June 2017 [6].
December 16, 2024: BD Pays $175 Million SEC Penalty
BD agreed to pay a $175 million civil penalty to settle the SEC investigation into its Alaris disclosures [7]. BD neither admits nor denies the SEC findings.
December 26, 2023: BD Files $85 Million Investor Settlement
BD announced it had filed settlement documents for an $85 million agreement to resolve the investor class action in the U.S. District Court for the District of New Jersey, with no admission of liability [8].
According to Drug Delivery Business, BD denied any wrongdoing. The settlement resolves claims by investors and pays no patients. The case is Industriens Pensionsforsikring v. Becton, Dickinson and Company, et al.
December 21, 2023: Investors Seek Approval of $85 Million Deal
A class of Becton Dickinson investors asked a New Jersey federal judge for preliminary approval of an $85 million settlement. The deal resolves securities fraud claims over the Alaris infusion pump [9].
August 11, 2022: Judge Allows Part of Investor Suit to Proceed
Judge Stanley R. Chesler of the District of New Jersey issued an opinion. It allowed part of the investor lawsuit to proceed against BD and CEO Thomas Polen [10].
February 27, 2020: Investors File Class Action Against BD
Industriens Pensionsforsikring filed its investor class action against Becton, Dickinson and Company in federal court in New Jersey. The suit alleged that BD failed to disclose Alaris defects.
What Is the Alaris Pump?
According to the FDA correction alert, the BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system [11]. It gives fluids to adult, pediatric and neonatal patients.
It can run on a steady or an on-and-off schedule. The recalls on this page involve the Alaris Pump Module 8100, its compatible infusion sets and the bezel assembly of the module.
Who May Be Affected?
Patients in a hospital or other care setting may be affected. They got fluids or medicines through a BD Alaris Pump Module 8100 or a compatible infusion set. The recalls also reach modules serviced with previously recalled bezel kit assemblies.
The FDA names neonates, pediatric patients and critically ill patients as the most vulnerable. These patients more often receive low-rate or low-volume infusions, such as antiarrhythmics or blood-pressure supporting medications.
Whether your own case fits depends on your records and your facts. Only an individual legal review can answer that.
Reported Injuries or Damages
Recall notices describe the risk of free flow, over-infusion, under-infusion or interruption of infusion. These are company and FDA reports and are not court findings.
BD said the bezel kit recall “has been associated with incidents of serious injury and patient death”. BD reported two serious injuries and no deaths for the dropped-pump issue.
BD had not reported serious injuries or deaths for the infusion set issue as of August 19, 2026. BD told Medtech Dive it received two complaints of serious injury between January 2016 and June 2025.
The SEC order, as Medtech Dive reported, says BD had found 37 serious software flaws in the pump by October 2019 [12].
Recall and Regulatory Background
The FDA classed the Alaris Pump infusion set issue as a Class I recall and lists it as ongoing. A separate Class I correction alert covers pump modules that were dropped or severely jarred.
Earlier BD notices from 2019 are listed as terminated [13]. A recall does not prove liability. Our Alaris infusion pump recall page covers the recall details.
Evidence to Preserve
Keep the following records and items if an Alaris pump may have been involved in an injury:
- The pump module and infusion set identifiers, such as the model, catalog number, and lot or serial number.
- Any bezel kit service record for the pump module.
- The name of the hospital or facility, the dates, and the drugs infused.
- Medical records and bills that show the treatment and its cost.
- Incident reports and your communications with the hospital or BD.
- Photographs of the device and any damage to it.
- Any MedWatch report numbers [14].
Filing Deadlines
State law sets the time limit for an injury claim. Your limit depends on your home state and on the date of the injury.
In some states, the clock starts at the diagnosis and not at the injury, so the date of diagnosis can matter to a claim.
A missed deadline can end a claim even with strong facts, so talk to a lawyer promptly about your own dates.
Frequently Asked Questions
How Do I Report an Alaris Pump Problem?
You can report an Alaris pump problem to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch. You can also reach the BD Complaint Center at 1-844-823-5433 or productcomplaints@bd.com.
What Does the Research Say About Alaris Pump Software Flaws?
The research on Alaris pump software flaws comes from an SEC order. According to that order, BD first told the FDA about the serious flaws in the same month it found them, and BD neither admits nor denies the SEC findings.
Does an Alaris Pump Recall Prove BD Is Liable?
An Alaris pump recall does not by itself prove BD is liable. Reports are not proof that the pump caused each incident. BD described the bezel kit recall as voluntary, and a court has not ruled on patient injury claims.
Is the Alaris Bezel Kit Recall a Global Recall?
The Alaris bezel kit recall is a voluntary global recall. BD’s July 15, 2025 notice says the recall covers Alaris and BD Alaris pump modules serviced with legacy bezel kit assemblies.