Alaris Infusion Pump Recall | 2026 Latest Updates

Becton, Dickinson and Company (BD) has recalled or corrected several BD Alaris infusion pump components since 2020. The newest is BD’s October 17, 2025 notice telling customers not to use a dropped or jarred pump module.

The recall covers the Alaris Pump Module 8100, bezel kit assemblies, and several Alaris Pump Infusion Set models. Each is tied to a different defect that can affect how accurately a pump delivers medication.

Patients and families should ask their care team whether an affected pump or infusion set was recently used, and avoid using one that was dropped or jarred. The FDA lists the infusion-set, bezel-kit, and dropped/jarred-pump recalls as Open.

Latest Alaris Infusion Pump Recall Updates

October 17, 2025: BD Tells Customers Not to Use a Dropped or Jarred Pump

BD sent all customers a letter about pump modules that had been dropped or severely jarred [1]. It told them not to use such a pump until biomedical engineering had inspected it.

Damage inside the pump’s bezel assembly may not be visible from the outside. BD had reported two serious injuries and no deaths tied to this issue as of September 22, 2025.

September 12, 2025: Recall Expanded to 15 More Infusion Sets

BD expanded its Class I recall of BD Alaris Pump Infusion Sets [2]. The update added 15 more, previously discontinued sets that may still sit in facility inventory.

BD also shared new corrective steps and recommended alternate infusion sets where available. It sent a full list of the newly added sets to every affected customer.

July 17, 2025: Recall Expanded with New Performance Data

CareFusion, a BD subsidiary, expanded the July 8 recall on July 17 [3]. The update added sets left off the first notice and published new performance data for the Pump Module 8100.

The new data showed that some compatible infusion sets could delay an occlusion alarm. Others could shift bolus-dose accuracy beyond the ranges in BD’s own user manuals.

July 15, 2025: Bezel Kit Recall Updated After Injury and Death Reports

BD updated its global recall of Alaris and BD Alaris Pump Modules serviced with legacy bezel kit assemblies [4]. These kits were made between April 2011 and June 2017 and were first recalled in 2019.

BD’s own notice ties this bezel defect to injury and death reports, without a case count. It told customers to dispose of affected kits and inspect any pump that may have used one.

July 8, 2025: FDA Recall Z-2180-2025 Initiated

CareFusion 303, a BD subsidiary, opened the Class I action that later became Recall Z-2180-2025 [5]. The action covers BD Alaris Pump Infusion Sets whose flow-rate and bolus-accuracy could fall outside BD’s own user-manual ranges.

The FDA posted the action on August 6, 2025 as Recall Number Z-2180-2025, its most serious classification. The record lists 33,162,680 units in commerce and a status of Open, Classified.

March 20, 2025: FDA Posts Software Correction Notice

The FDA posted a correction notice for BD Alaris Systems Manager and CCE Infusion Adapter software [6]. The software could backlog automated requests and show a user outdated infusion settings.

BD had already sent a correction letter to customers on February 18, 2025. It asked them to confirm every pre-set infusion value before starting an infusion, and it reported no injuries or deaths.

December 16, 2024: SEC Orders BD to Pay $175 Million Penalty

The Securities and Exchange Commission ordered BD to pay a $175 million civil penalty [7]. The penalty addressed misleading investor statements about Alaris pump defects and the device’s FDA clearance status.

The SEC’s order addressed BD’s investor-disclosure failures under the securities laws. It did not find BD liable for any patient injury, and it is separate from any lawsuit brought by an injured patient.

April 22, 2024: Court Approves $85 Million Investor Settlement

A New Jersey federal court approved an $85 million settlement in Industriens Pensionsforsikring A/S v. Becton, Dickinson and Company. The court entered final judgment on April 22, 2024, in Case No. 2:20-cv-02155-SRC-CLW.

The case was a securities class action over BD’s disclosures to shareholders about the Alaris system. It was not a settlement of any injured patient’s claim, and BD denied wrongdoing while agreeing to the deal.

December 19, 2023: FDA Classifies Syringe-Compatibility Correction

The FDA classified a labeling correction as a Class I recall [8]. BD had found that rebranded Cardinal Health Monoject syringes were not validated for the Alaris Syringe and PCA Modules.

Using the new syringes with old pump settings could make a pump refuse to operate. It could also make the pump misjudge fluid volume, causing over- or under-infusion or a delay in therapy.

July 21, 2023: BD Receives FDA Clearance for Updated Alaris System

BD received FDA 510(k) clearance for an updated BD Alaris Infusion System [9]. The clearance covered new hardware, software, and cybersecurity features.

The clearance let BD resume full commercial distribution of the updated system. BD then began fixing or swapping out older devices, ending a shipping hold in place since 2020.

August 20, 2020: FDA Classifies Hardware Recall as Class I and Class II

The FDA reviewed a hardware recall BD had announced on June 30, 2020, and classified three problems as Class I [10]. Those were damaged connectors between pump units, broken pump-module platen parts, and a loose PC-unit battery.

A fourth problem, dim LED lights on the Alaris modules, was classified Class II, a milder category. The FDA published this update on September 1, 2020.

Which Alaris Infusion Pumps Are Affected?

The recalled and corrected products span several BD Alaris system parts. FDA and BD notices name them by model, catalog, and lot number:

• Alaris Pump Module 8100 – covered by both the bezel kit recall and the dropped/jarred-pump correction
• Legacy bezel kit assemblies – serviced onto the Pump Module; manufacture dates are given in the July 15, 2025 update below
• BD Alaris Pump Infusion Sets – multiple catalog numbers under Recall Z-2180-2025
• Systems Manager/CCE software – specific versions named in the March 2025 notice below

These are hospital devices, not something a patient buys. A facility’s biomedical or purchasing staff can match the exact model and lot numbers in use against BD’s customer letters.

Why Were the Alaris Infusion Pumps Recalled?

The Alaris infusion pumps and infusion sets were recalled because of several hardware and manufacturing defects. These defects can cause a pump to give too much or too little medication, and each has its own cause.

Legacy bezel kit assemblies were made with a plastic that weakens over time. This can let the bezel crack and cause free flow, over-infusion, under-infusion, or a stopped infusion. That defect is described in the Reported Incidents section below.

Separately, a pump module that has been dropped or jarred can suffer hidden damage to that same bezel part. This can also cause an inaccurate infusion.

A third cause involves the infusion sets themselves. Some sets perform outside the flow-rate, dose-accuracy, and alarm ranges in BD’s own manuals, especially at very low flow rates.

A fourth cause is a software backlog in the Systems Manager. It can leave a user looking at stale infusion settings in the middle of a procedure.

Reported Incidents, Injuries, or Illnesses

The reported harm varies by which Alaris defect is involved. The figures below come separately from BD’s and the FDA’s own notices. No single combined count covers every action.

For the bezel kit issue, BD’s own notice links the defect to reports of serious injury and death. It does not publish how many reports it received.

BD’s October 2025 notice (above) reports two injuries and no deaths as of September 22, 2025. Those figures cover pump modules that were dropped or jarred. The infusion-set issue carried no reported injuries or deaths as of June 11, 2025.

The March 2025 software notice also reported no injuries or deaths tied to that issue, based on BD’s own account.

Each figure reflects what a notice had confirmed as of its own date. Later reports could change any of them, and a reported incident does not by itself prove a pump caused it.

What Should Consumers Do?

Because Alaris pumps and infusion sets are hospital and clinic equipment rather than something a patient buys, a patient or family member concerned about this recall should:

1. Ask your hospital, clinic, or home-infusion provider about your care. Find out whether an affected Alaris pump module, bezel kit, or infusion set was used, and ask the same question if the care involved a family member
2. Tell the care team right away if a pump was recently dropped or jarred. It can then be pulled from use and checked before its next use
3. Watch for signs that a medication was delivered too fast or too slow, such as unexpected drowsiness, pain, or a change in condition. Alert a nurse or doctor right away
4. Keep any paperwork, discharge summaries, or billing records that name the device or infusion equipment used during treatment
5. Report a suspected problem to BD’s Technical Support at 888-812-3229 or DL-US-INF-TechSupport@bd.com. You can also reach the FDA’s MedWatch program at 1-800-FDA-1088

Other Recalls, Warnings, or International Actions

Health Canada issued its own safety notice in 2019. It covered a separate, earlier over-infusion defect in Alaris Pump Infusion Sets used with the Alaris 8100 Pump Module [11]. Canadian hospitals had reported medication delivered incorrectly.

That 2019 notice covers a separate, earlier Canadian action that came about six years before the 2025 US actions described above.

Legal Options

No combined federal MDL or class action has formed yet for the patients nationwide who say these Alaris devices caused them serious harm [12].

A recall does not automatically prove a company is liable, or that a patient can file a claim. But the bezel-kit defect described above is why some patients look into an individual medical device lawsuit review.

The $175 million SEC penalty and $85 million securities settlement described above went to BD’s investors rather than injured patients. Neither one pays a patient directly.

Filing Deadlines

Deadlines for filing a legal claim come from state law, not from this recall. How much time a patient or family has depends on where they live and when the injury, death, or diagnosis happened.

Some states start the clock later, at the date of diagnosis rather than the date of exposure or injury. That difference can change how much time is left to act.

Missing a filing deadline can end a claim even when the medical facts are strong. Anyone who believes an Alaris pump or infusion set played a role should check with a lawyer promptly.

Frequently Asked Questions

What Countries Received the Recalled BD Alaris Pump Infusion Sets?

The recalled BD Alaris Pump Infusion Sets reached facilities nationwide in the United States. The FDA’s recall record for Z-2180-2025 also lists healthcare facilities in Japan, Italy, Germany, and Turkey.

What Are the Bezel Kit Catalog Numbers in the Alaris Infusion Pump Recall?

The Alaris bezel kit recall lists two catalog numbers. Number 49000437 covers the bezel assembly kit, and 49000270 covers the one-piece bezel assembly kit, both used to service the Pump Module 8100.

What Is the BD Alaris Infusion System?

The BD Alaris Infusion System is a modular infusion pump and monitoring system used in hospitals. It delivers fluids to adult, pediatric, and neonatal patients. These fluids move through routes including IV, intra-arterial, subcutaneous, epidural, or irrigation of fluid spaces, per BD’s own device-use description.

Has BD Settled Any Lawsuits over the Alaris Infusion Pump?

BD has settled a lawsuit over the Alaris infusion pump, but it was an investor securities case rather than a claim for patient injury. Court records name BD and its then-CEO, Thomas E. Polen, as defendants in the $85 million settlement, which paid BD’s shareholders, separate from any patient-injury claim.

Which BD Alaris Systems Manager Software Versions Are Affected by the March 2025 Correction?

The affected BD Alaris Systems Manager software versions are v12.5.1 and v12.5.2. Earlier affected versions include 4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, and 12.3. The affected CCE Infusion Adapter software is version 1.7.2.

How Do I Return a Customer Response Form for the Alaris Infusion Pump Recall?

You return a BD Alaris recall customer response form by emailing it to bdrc55@bd.com or faxing it to 312-949-0083. BD lists these contacts specifically for acknowledging receipt of its recall notices.

References

1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-becton-dickinson-updates-use-instructions-bd-alaris-pump-issue
2. https://news.bd.com/2025-09-12-BD-Provides-Update-on-Voluntary-Recall-of-Certain-BD-Alaris-TM-Pump-Infusion-Sets
3. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/update-alert-infusion-set-performance-issue-bd
4. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-issues-update-voluntary-global-recall-alaristm-and-bd-alaristm-pump-modules-serviced-legacy-bezel
5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214860
6. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/infusion-pump-software-correction-becton-dickinson-and-company-bd-issues-correction-bd-alaris
7. https://www.sec.gov/files/litigation/admin/2024/33-11344.pdf
8. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/becton-dickinson-bdcarefusion-303-recalls-alaris-infusion-pumps-due-compatibility-issues-cardinal
9. https://news.bd.com/2023-07-21-BD-Receives-FDA-510-k-Clearance-for-Updated-BD-Alaris-TM-Infusion-System
10. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-previously-disclosed-recall-bd-alaris-system-hardware
11. https://recalls-rappels.canada.ca/en/alert-recall/important-safety-information-alaris-infusion-sets-and-alaris-8100-pump-module-risk
12. https://www.jpml.uscourts.gov/pending-mdls-0