Highest risk U.S. Food and Drug Administration

BD Alaris BD Alaris Pump Module model 8100 used with a subset of compatible pump recall: Pump performance variations compared to the performance described in the user

Recall published 1+ years ago

Pump performance variations compared to the performance described in the user manual could impact infusion delivery

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: The affected products have the potential to result in patient death or serious adverse events, with a particular higher risk to vulnerable patient populations such as neonates and critically ill patients.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
September 12, 2025
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
BD Alaris
Product type
Medical devices
Distribution
Nationwide

Products covered by this recall

BD Alaris Pump Module model 8100 used with a subset of compatible pump infusion sets

What the company announced

FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performance, under certain use cases, for the BD Alaris™ Pump Module model 8100 when used with a subset of compatible pump infusion sets, as compared to the performance described in the user manual. The update includes an expansion of 15 additional impacted pump infusion sets included in the recall, as well as new corrective actions and risk information. The 15 additional sets had been previously discontinued but may remain in inventory based on the expiration date.

This issue was identified through internal testing and, to date, BD has not received any complaints associated with this issue. The affected products have the potential to result in patient death or serious adverse events, with a particular higher risk to vulnerable patient populations such as neonates and critically ill patients. The recall has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA).

Pump performance variations as compared to the performance described in the user manual could impact infusion delivery in the following ways:

Flow rate and loading bolus dose accuracy (over/under infusion),

Upstream and downstream occlusion alarm delay,

and post-occlusion bolus volume (POBV) over infusion,

which could adversely impact infusion performance and dose accuracy. The severity and nature of these outcomes depend on the type of medication, fluid, or infusate being administered, as well as the individual patient’s condition.

The deviations in performance from the previously published ranges are attributable to these pump infusion sets' design features, such as filters and other in-line components. The products included in the recall were distributed nationwide in the United States, including Guam and Puerto Rico, and in Canada, Belgium and South Africa.

In an update sent to all customers on September 11, 2025, BD shared updated corrective actions, including risk mitigations and recommendations for alternate BD Alaris™ Pump infusion sets to use when available and clinically appropriate. The customer update also included a list of the 15 additional impacted pump infusion sets included in the recall. Information about this recall is available on BD's website or by calling BD at 1-888-562-6018.

Customers should report any complaints experienced with the use of this product to the BD Complaint Center at 1-844-823-5433, Monday – Friday between the hours of 9 a.m. and 6 p.m. ET or by emailing [email protected] .

FDA MedWatch Reporting

Adverse reactions/events experienced with the use of this product should be reported to the FDA's MedWatch Program by:

Online: Complete and submit the report at www.fda.gov/medwatch/report.htm

Call 1-800-FDA-1088 (1-800-332-1088)

Regular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ , X (formerly Twitter) @BDandCo or Instagram @becton_dickinson .

Contacts:

Media:

Fallon McLoughlin

Director, Public Relations

201.258.0361

[email protected]

Investors:

Adam Reiffe

Sr. Director, Investor Relations

201.847.6927

[email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • 8100

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

BD Alaris — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: BD — Consumers: BD Complaint Center, 1-844-823-5433 — Media: Fallon McLoughlin, Director, Public Relations, 201.258.0361, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was BD Alaris medical devices recalled?

Pump performance variations compared to the performance described in the user manual could impact infusion delivery The affected products have the potential to result in patient death or serious adverse events, with a particular higher risk to vulnerable patient populations such as neonates and critically ill patients.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 8100. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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