BD Intraosseous Vascular Access System recallZ-2872-2026 · Bard Access Systems, Inc. · initiated Jul 30, 2026

Why it was recalled

After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy

FDA root cause category: Component change control

What the company is doing

On 7/30/2026, recall notices were mailed/emailed: 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. Alternate vascular access approaches, including additional peripheral IV attempts, or central venous access may continue to be pursued based on clinical judgment/protocols. Affected product should not be used to establish IO access. For patients in whom potentially affected intraosseous needles are currently in use/or have been used and are/were functioning properly, no additional steps need to be taken. 1. Destroy all affected needle set kits, or quarantined until disposal. 2. Provide a copy of this notification to any customers and/or facilities you may have distributed devices to. 3. Complete and return the attached Customer Response Form via email to [email protected] Distributors were also asked to do the following: - A customer letter template is provided to create your own letter to be sent to all customers. - Provide product replacement for all product destroyed by your customer. Questions contact firm at 1-844-823-5433 or [email protected] Firm has acquired new molds with improved dimensional controls. Instructions For Use will be updated with the following to optimize needle / obturator(stylet) / drill handling: Do not pull back on the drill and needle, release the trigger prematurely, or rock/bend the needle during insertion. These actions may result in the needle and drive adapter hubs to rotate and lock together resulting in a bent needle, difficult stylet removal, need for a new device, and/or delay in therapy. Warning: Do not rotate or try to unscrew the drive adapter hub while removing the stylet. These actions may cause the needle and drive adapter hubs to rotate and lock together, resulting in difficult stylet removal, need for a new device, and/or delay in therapy.

Recall details

Recall number

Z-2872-2026

Status

Open, Classified

Initiated by the company

Jul 30, 2026

Posted by the FDA

Aug 14, 2026

Recalling firm

Bard Access Systems, Inc.

Quantity

80,200

Product code

FMI

FDA submissions

K191976, K203193

Distribution

US: MA, FL, IA, SC, IL, NY, UT, NJ, ID, IN, PA, CA, TX, OH, MO, VA, MD, NC, AL, MN, CO, KY, LA, NV, OK, MS, AZ, MI, GA, AR, KS, TN. OUS: CA, SG

Product description

BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Driver 55mm x 15Ga, REF: D015551NK

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

• BD Intraosseous Vascular Access System D015251NK

  Bard Access Systems, Inc. · Needle, hypodermic, single lumen
  2 recalls3 deaths47 reports
• BD Intraosseous Vascular Access System D015451NK

  Bard Access Systems, Inc. · Needle, hypodermic, single lumen
  2 recalls1 death35 reports
• BD Intraosseous Vascular Access System D015151NK

  Bard Access Systems, Inc. · Needle, hypodermic, single lumen
  2 recalls1 death9 reports
• BD Intraosseous Vascular Access System D015551NK

  Bard Access Systems, Inc. · Needle, hypodermic, single lumen
  2 recalls1 death3 reports
• BD Intraosseous Vascular Access System D015351NK

  Bard Access Systems, Inc. · Needle, hypodermic, single lumen
  2 recalls2 reports

Product lines

• BD Intraosseous Vascular Access SystemBard Access Systems, Inc. · 11 models · 151 reports · 2 recalls