BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251

FDA device recall Z-2872-2026 · posted 2026-08-14 · Open, Classified

Recall details

Recalling firm

Bard Access Systems, Inc.

Reason for recall

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

Action taken

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 bdrc16@bd.com 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 productcomplaints@bd.com 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.

Root cause

Component change control

Status

Open, Classified

Product code

FMI

Quantity affected

80,200

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

Date initiated

2026-07-30

Date posted

2026-08-14

Location

Salt Lake City, UT

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