FDA Classifies BD Intraosseous Needle Set Recall as Class I
FDA has classified the recall of specified BD Intraosseous Vascular Access System Needle Set lots as Class I after out-of-tolerance dimensions were linked to difficulty removing the obturator and potential delays in therapy; the FDA recall database lists Bard Access Systems, Inc. as the recalling firm.
Decision support
Decision summary
FDA-sourced recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
Specified BD Intraosseous Vascular Access System Needle Set lots have out-of-tolerance dimensions that can allow the obturator, or stylet, to rotate and lock to the needle hub during insertion. If the obturator cannot be removed, another vascular-access route may be needed and therapy may be delayed. FDA classified the recall as Class I.
MedTech Current analysis
Why it matters
The issue can delay urgent vascular access for critically ill patients, including people experiencing out-of-hospital cardiac arrest or severe trauma. FDA reported 45 serious injuries and four deaths associated with the issue as of July 22, 2026.
Actions by role
MedTech Current analysis — editorial interpretation, not FDA-authored guidance.
- MedTech Current analysisManufacturers and suppliersverify dimensional-control, lot-release, complaint-escalation, and downstream traceability controls for comparable needle-obturator interfaces.
- MedTech Current analysisHealthcare facilities and professionalsidentify affected lots, stop use, quarantine or destroy them as instructed, and ensure alternate vascular-access options are available.
- MedTech Current analysisGeneral MedTech readersdistinguish FDA's official recall facts from these role-based operational interpretations and follow the linked FDA notice for updates.
Official recall information
Official actions
- Affected customers should immediately discontinue use of affected lots, check inventory, and destroy or quarantine affected needle set kits.
- Clinical users should not use affected products to establish intraosseous access; no additional action is needed for a needle already functioning or previously removed.
- Distributors should identify downstream customers, send notifications, and provide replacement or credit for destroyed products.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
Becton Dickinson (BD) is removing specified lots of its Intraosseous Vascular Access System Needle Sets after identifying out-of-tolerance dimensions that can allow the obturator, or stylet, to rotate and lock to the needle hub during insertion. If the obturator cannot be removed, a clinician may need to establish vascular access with another intraosseous needle or another device, potentially delaying therapy. The FDA has classified the recall as Class I.
The FDA first issued an Early Alert for the issue on August 4, 2026, and updated the communication on August 17 after the event was classified as a Class I recall. According to the FDA communication, BD had reported 45 serious injuries and four deaths associated with the issue as of July 22, 2026. The communication states that critically ill patients requiring urgent vascular access, including patients with out-of-hospital cardiac arrest or severe trauma, are at greatest risk from a delay in therapy.
Who and what are affected
The FDA recall database identifies Bard Access Systems, Inc. as the recalling firm and manufacturer. Recall number Z-2872-2026 covers specified lots of five BD Needle Kit for Powered Driver configurations, with 80,200 units listed in commerce.
| Product | Catalog number | UDI-DI |
|---|---|---|
| BD Needle Kit for Powered Driver 15mm x 15Ga | D015151NK | 00801741163586 |
| BD Needle Kit for Powered Driver 25mm x 15Ga | D015251NK | 00801741163678 |
| BD Needle Kit for Powered Driver 35mm x 15Ga | D015351NK | 00801741163593 |
| BD Needle Kit for Powered Driver 45mm x 15Ga | D015451NK | 00801741163609 |
| BD Needle Kit for Powered Driver 55mm x 15Ga | D015551NK | 00801741163616 |
Only specified lots are affected. The complete lot list is available through the primary FDA recall notice.
What affected organizations should do
BD’s July 30 customer communication provides separate instructions for affected customers, clinical users, and distributors.
Affected customers and facilities
BD instructed affected customers to:
- Immediately discontinue use of affected lots.
- Check inventory locations for affected needle set kits.
- Destroy affected needle set kits according to facility procedures.
- Quarantine affected products until disposal if immediate destruction is not possible.
- Provide the notification to downstream customers or facilities if affected devices were redistributed.
Clinical users
According to the FDA communication:
- Affected products should not be used to establish intraosseous access.
- No additional steps are needed if a potentially affected needle is already in use and functioning properly, because the issue occurs during insertion.
- No additional follow-up is required if a potentially affected needle was previously used and has already been removed.
Distributors
BD instructed distributors to:
- Check inventory for affected products.
- Destroy or quarantine affected products.
- Identify customers that received affected devices.
- Send downstream notifications.
- Provide product replacement or credit for products destroyed by customers.