BD (Intraosseous Vascular Access System Needle Sets/(Becton, Dickinson and Company)) Recall reason: Due to Reports of Difficulty Removing the Obturator

COMPANY ANNOUNCEMENT

BD Issues Nationwide Recall for Specific Lots of BD® Intraosseous Vascular Access System Needle Sets Due to Reports of Difficulty Removing the Obturator

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Summary

Company Announcement

FRANKLIN LAKES, N.J. (July 31, 2026) - BD (Becton, Dickinson and Company) is voluntarily recalling specific lots of BD® Intraosseous Vascular Access System Needle Sets to the user level. These products are being recalled following reports that some users experienced difficulty removing the obturator (stylet) after placement of the needle set. Based on complaint reports, bench testing completed by BD and clinical observations, this may occur if the drill is not pulled straight back during insertion or if the obturator is incorrectly rotated during removal.

The affected lots were manufactured with out of tolerance dimensions and distributed between September 30, 2024, and June 12, 2026. This recall does not affect the BD® Intraosseous Powered Driver.

Risk Statement: If the obturator cannot be removed, the clinician may need to obtain a new IO needle or alternative vascular access device, such as a Peripheral IV catheter, potentially delaying therapy initiation. Patients at greatest risk are critically ill individuals requiring urgent vascular access, including out-of-hospital cardiac arrest and severe trauma patients. Delays to therapy initiation may result in serious injury or death. Through June 2026, BD has received 75 complaints and reported 45serious injury reports. BD has also reported 4 deaths in which the inability to remove the stylet occurred during resuscitation efforts for out-of-hospital cardiac arrests.

*Additional information can be found in the customer letter, available here.

BD is notifying its customers and distributors who may have received these lots of product directly. Customers and distributors should immediately discontinue use of these lots and destroy all affected needle sets in accordance with their facility's process.

BD will issue replacement for destroyed product of the affected lot numbers to customers that purchased the affected product directly from BD, following receipt of the completed Customer Response Form.

BD has identified the root cause of this issue and implemented corrective and preventative action, including product and labeling improvements, to enhance device robustness and reduce the likelihood of recurrence. Product distributed outside of the affected production window is not impacted.

Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD's North American Regional Complaint Center: 1-844-823-5433 (Toll Free) Monday - Friday between the hours of 8 a.m. and 5 p.m. CT or by emailing: [email protected].

FDA MedWatch Reporting

Adverse reactions/events experienced with the use of any of these products should also be reported to the FDA's MedWatch Adverse Event Reporting program either online, phone or by regular mail.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Call 1-800-FDA-1088 (1-800-332-1088)
• Regular Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852-9787

The U.S. Food and Drug Administration (FDA) has been notified of this recall.

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About BD
BD is one of the world's largest pure-play medical technology companies with a Purpose of advancing the world of health™ by driving innovation across medical essentials, connected care, biopharma systems and interventional. The company supports those on the frontlines of healthcare by developing transformative technologies, services and solutions that optimize clinical operations and improve care for patients. Operating across the globe, with more than 60,000 employees, BD delivers billions of products annually that have a positive impact on global healthcare. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase clinical efficiency, improve safety and expand access to healthcare. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X @BDandCo or Instagram @becton_dickinson.

Contacts:

Media
Matt Marcus
VP, Public Relations
[email protected]

Investors
Shawn Bevec
SVP, Investor Relations
[email protected]

• Content current as of:

  08/03/2026

• Regulated Product(s)

  • Medical Devices

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