FDA recall Z-2872-2026

Bard Access Systems, Inc. · Class I · device

Product

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

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

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

Key facts

Status
Ongoing
Initiation date
2026-07-30
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2872-2026