BD Issues Nationwide Recall of Intraosseous Vascular Access Needle Sets Linked to Four Deaths
核心洞察
BD is voluntarily recalling specific lots of its Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator after placement.
The affected lots were manufactured with out-of-tolerance dimensions and distributed between September 30, 2024, and June 12, 2026.
BD has received 75 complaints, including 45 serious injury reports and 4 deaths during resuscitation efforts for out-of-hospital cardiac arrests.
BD (Becton, Dickinson and Company) (搜索) is voluntarily recalling specific lots of its BD® Intraosseous Vascular Access System Needle Sets (搜索) to the user level, following reports that some users experienced difficulty removing the obturator (stylet) after placement of the needle set. The recall, announced July 31, 2026, follows a Food and Drug Administration early alert posted Tuesday.
The affected lots were manufactured with out-of-tolerance dimensions and distributed between September 30, 2024, and June 12, 2026. Based on complaint reports, bench testing completed by BD, and clinical observations, the difficulty may occur if the drill is not pulled straight back during insertion or if the obturator is incorrectly rotated during removal. For needles manufactured with incorrect dimensions, certain actions can allow rotation and locking where the obturator and needle meet.
The recall does not affect the BD® Intraosseous Powered Driver.
Clinical Risk and Reported Outcomes
The intraosseous needles are used to provide access to the bone marrow in emergency care situations when intravenous access is difficult. If the obturator cannot be removed, the clinician may need to obtain a new intraosseous needle or an 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 (搜索) 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 45 serious 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.
Corrective Actions and Customer Instructions
BD has identified the root cause of the 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.
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.
The U.S. Food and Drug Administration (FDA) has been notified of this recall. Adverse reactions or events experienced with the product should be reported to BD's North American Regional Complaint Center or to the FDA's MedWatch Adverse Event Reporting program.