FDA Recall: BD Intraosseous Vascular Access Needle Sets — Obturator Removal Risk
Quick take: Becton, Dickinson and Company (BD) has issued a nationwide recall of specific BD® Intraosseous Vascular Access System Needle Sets after clinicians reported difficulty removing the obturator (stylet). Affected devices can delay life-saving therapy for critically ill patients. Check the catalog and lot numbers below, discontinue use immediately, and destroy affected stock as instructed.
Why the BD Intraosseous needle sets are being recalled
Between September 2024 and June 2026, BD shipped several lots of its powered-driver intraosseous (IO) needle kits with out-of-tolerance dimensions. These flaws can make the obturator difficult—or impossible—to remove once the needle is placed. BD has documented:
- 75 customer complaints
- 45 serious injury reports
- 4 patient deaths during out-of-hospital cardiac resuscitation
If removal fails, clinicians must restart vascular access with a new IO needle or a peripheral IV, delaying urgent drug or fluid administration. Such delays can lead to serious injury or death, especially in trauma or cardiac-arrest cases.
Catalog numbers included in the BD recall
| Product | Catalog No. | UDI-DI |
|---|---|---|
| Needle Kit 15 mm × 15 Ga | D015151NK | 00801741163586 |
| Needle Kit 25 mm × 15 Ga | D015251NK | 00801741163678 |
| Needle Kit 35 mm × 15 Ga | D015351NK | 00801741163593 |
| Needle Kit 45 mm × 15 Ga | D015451NK | 00801741163609 |
| Needle Kit 55 mm × 15 Ga | D015551NK | 00801741163616 |
Lot numbers and expiration dates vary. Refer to Appendix 1 in BD’s customer letter for complete details.
Sources
Immediate actions for clinicians & supply managers
- Stop using and isolate the recalled needle sets listed above.
- Destroy all affected inventory per your facility’s protocol.
- Complete BD’s Customer Response Form to receive free replacements.
- Report adverse events to BD at 1-844-823-5433 or productcomplaints@bd.com.
- Submit reports to FDA MedWatch via the online form or call 1-800-332-1088.
BD contact information
BD North American Regional Complaint Center
Phone: 1-844-823-5433 (Mon–Fri, 8 a.m.–5 p.m. CT)
Email: productcomplaints@bd.com
BD Intraosseous recall – Frequently asked questions
Is the BD® Intraosseous Powered Driver affected by this recall?
No. BD states the powered driver itself is not included in the recall—only the needle sets listed above.
How do I obtain replacement BD Intraosseous needle sets?
After destroying the affected lots, return BD’s completed Customer Response Form to receive replacement product at no charge.
Can I keep unaffected BD Intraosseous needle set lots in service?
Yes. Only lots manufactured between September 30 2024 and June 12 2026 with the catalog numbers shown above are recalled.
Which patients face the highest risk from delayed BD Intraosseous access?
Critically ill patients who need immediate vascular access—such as out-of-hospital cardiac-arrest or severe-trauma victims—face the greatest risk from therapy delays.
Do I need to notify patients already treated with BD Intraosseous needle sets?
No post-procedure patient action is required. The hazard occurs during insertion; once therapy is underway, the risk has passed.
Where can I read the official FDA announcement about the BD Intraosseous needle recall?
The FDA-posted company announcement is available here.
How do I identify a recalled BD Intraosseous Vascular Access System Needle Set?
Match both the catalog number and lot number on your product packaging to the lists provided in BD’s customer letter (Appendix 1). If both numbers appear, the item must be destroyed.
Will BD reimburse costs related to the recall of BD Intraosseous needle sets?
BD offers free replacement products but directs customers to contact their sales representative regarding reimbursement for ancillary costs such as disposal or staff time.