BD Intraosseous Vascular Access System Needle Sets recalled for difficult obturator removal
BD is recalling specific lots of its Intraosseous Vascular Access System Needle Sets because some users have had difficulty removing the obturator (stylet) after needle placement. The affected needle sets were manufactured with out-of-tolerance dimensions and distributed between September 2024 and June 2026. If the obturator cannot be removed, clinicians may need to obtain alternative vascular access, potentially delaying urgent care.
From the FDA notice · Read the official notice ↗ · All BD recalls
What to do
- If you use these needle sets, stop using the affected lots immediately and destroy them per your facility's procedures.
- Check the product lot numbers listed in the recall notice against your inventory.
- Contact BD at 1-844-823-5433 (Mon–Fri, 8 a.m.–5 p.m. CT) or productcomplaints@bd.com with questions or to request replacements.
- Report any problems with these products to FDA MedWatch at 1-800-FDA-1088 or online at fda.gov/medwatch.
Is yours affected?
Compare your label or packaging with the recalled product.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Illnesses reported
- Yes
In the FDA's words
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.
Read the full announcementShow less
Product Name
Catalog No.
Lot No.
UDI-DI
Expiration Date
Product Package Size
Needle Kit for Powered Driver 15mm x 15Ga
D015151NK
See Appendix 1 in customer letter*
00801741163586
See Appendix 1 in customer letter*
6 kits per case
Needle Kit for Powered Driver 25mm x 15Ga
D015251NK
00801741163678
Needle Kit for Powered Driver 35mm x 15Ga
D015351NK
00801741163593
Needle Kit for Powered Driver 45mm x 15Ga
D015451NK
00801741163609
Needle Kit for Powered Driver 55mm x 15Ga
D015551NK
00801741163616
*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: productcomplaints@bd.com .
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 Matt.Marcus@bd.com
Investors Shawn Bevec SVP, Investor Relations Investor_Relations@bd.com