The FDA is aware that Becton Dickinson (BD) issued a letter on July 30, 2026 to affected customers recommending certain Intraosseous Vascular Access System Needle Sets be removed from where they are used or sold.
The BD Intraosseous Vascular Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
BD stated that some lots were manufactured with out-of-tolerance dimensions, and as a result some users have reported difficulty removing the obturator (stylet) following placement of the BD Intraosseous Vascular Access System Needle Sets. Based on complaint reports, bench testing completed by BD and clinical observations, this may occur when pulling back on the drill during the insertion or when failing to pull straight back with the powered driver or incorrectly rotating or trying to unscrew the obturator. These actions allow the rotation and locking of the obturator-needle hub interface for specific lots of the product with out-of-tolerance dimensions.
If rotation and locking occurs, the clinician may need to obtain a new IO needle or other form of vascular access device, such as a Peripheral IV catheter, which may result in a delay to therapy initiation. Patients at greatest risk are critically ill individuals requiring urgent vascular access, including out-of-hospital cardiac arrest and severe trauma patients. Delay to initiate therapy can result in serious injury or death.
As of July 22, 2026, BD has reported 45 serious injuries and four deaths associated with this issue.
On July 30, 2026, BD sent all affected customers a letter recommending the following actions:
- Please immediately discontinue use of the affected lot(s). Check all inventory locations within your facility and destroy all affected needle set kits in accordance with your facility’s process. If destruction is not immediately possible at your facility, then product should be quarantined until disposal.
- Provide a copy of this notification to any customers and/or facilities you may have distributed devices to.
For Clinical Users:
- The product that is impacted by this recall notification should not be used to establish IO access.
- Although IO access is an important option during resuscitation, unsuccessful IO placement does not necessarily represent exhaustion of all vascular access options. Alternate vascular access approaches, including additional peripheral IV attempts, or central venous access may continue to be pursued based on clinical judgment and institutional protocols
- For patients in whom potentially affected intraosseous needles are currently in use and are functioning properly, no additional steps need to be taken. This issue occurs during insertion only.
- For patients in whom potentially affected intraosseous needles have been used and are now removed, no additional follow-up activities are required.
If you or a loved one suffered serious harm (or worse) as a result of a defective medical device in the United States, you should promptly find a defective medical device lawyer in your state who may investigate your medical device claim for you and represent you or your loved one in a defective medical device case, if appropriate.
Click here to visit our website or call us toll-free in the United States at 800-295-3959 to find medical device attorneys in your U.S. state who may assist you.
Turn to us when you don’t know where to turn.
