Elevated risk U.S. Food and Drug Administration

Alaris™ and BD Alaris™ Pump Modules recall: May have been serviced with previously recalled bezel kit assemblies

Recall published 1+ years ago

May have been serviced with previously recalled bezel kit assemblies

The hazard: Foreign material — hard plastic

The company found hard plastic in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

What the notice says: These affected bezel kit assemblies were manufactured with a specific type of plastic material that weakens over time, leading to the potential of separated and/or broken bezel bosses that can cause free flow, over infusion, under infusion or interruption of infusion.

Why it matters: Pieces of hard plastic may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: most plastics are invisible on a plain X-ray, so the history you give is what the decision rests on.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
July 15, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Alaris™ and BD Alaris™
Product type
Medical devices

Products covered by this recall

Pump Modules

What the company announced

FRANKLIN LAKES, N.J. (July 15, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules that may have been serviced with previously recalled bezel kit assemblies.

BD is issuing this voluntary recall notice to reiterate that certain bezel kit assemblies that were manufactured between April 2011 and June 2017 and previously recalled in 2019 should not be used for service with the Alaris™ and BD Alaris™ Pump Module.

BD became aware via customer complaints of customer/third party usage of affected bezel kit assemblies to service Alaris™ and BD Alaris™ Pump Modules. These affected bezel kit assemblies were manufactured with a specific type of plastic material that weakens over time, leading to the potential of separated and/or broken bezel bosses that can cause free flow, over infusion, under infusion or interruption of infusion. This recall has been associated with incidents of serious injury and patient death.

The previous field action impacted bezel kit assemblies manufactured with the specific type of plastic material (FR-110 bezels) and used to service Alaris™ and BD Alaris™ Pump Modules (8100). However, as pump modules not originally manufactured with the affected bezel assembly may have been serviced by customers or a third party with the recall-affected bezel spare part, this recall is inclusive of all Alaris™ and BD Alaris™ Pump Modules.

BD is instructing customers to immediately dispose of any affected bezel kit assemblies remaining in their possession. BD is also instructing customers to check their records to determine if any of their pump modules may have been serviced with affected bezel kit assemblies and if so, to perform a visual inspection of the bezel. If an affected bezel is found, the pump should be removed from service and customers should contact BD for further instructions.

Information about this recall is available on BD's website or by calling BD at 1-888-562-6018. In addition, this updated notification will be sent to all customers starting July 15, 2025.

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 1800-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:

Troy Kirkpatrick

VP, Public Relations

858.617.2361

[email protected]

Investors:

Adam Reiffe

Sr. Director Investor Relations

201.847.6927

[email protected]

https://news.bd.com/2025-07-15-BD-Issues-Update-to-Voluntary-Global-Recall-of-Alaris-TM-and-BD-Alaris-TMPump-Modules-Serviced-with-Legacy-Bezel-Kit-Assemblies

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.

What to do about Plastic pieces

Alaris™ and BD Alaris™ — The company found hard plastic in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.
  3. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.
  4. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: BD is instructing customers to immediately dispose of any affected bezel kit assemblies remaining in their possession.

Company contact: Becton, Dickinson and Company — Consumers: Complaint Center, 1-844-823-5433 — Media: Troy Kirkpatrick, 858.617.2361, [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 Alaris™ and BD Alaris™ medical devices recalled?

May have been serviced with previously recalled bezel kit assemblies These affected bezel kit assemblies were manufactured with a specific type of plastic material that weakens over time, leading to the potential of separated and/or broken bezel bosses that can cause free flow, over infusion, under infusion or interruption of infusion.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

The notice says: BD is instructing customers to immediately dispose of any affected bezel kit assemblies remaining in their possession.

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