Recall Z-2872-2026— Bard Access Systems, Inc.

Name: FDA recall Z-2872-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-30

Class I · Ongoing

Class I FDA medical device recall by Bard Access Systems, Inc., initiated 2026-07-30. It names 2 FDA 510(k) clearances: K203193, K191976. 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: 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.

Recalling firm: Bard Access Systems, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-07-30
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

2 on FDA's record

K203193 — BD Intraosseous Infusion SystemBard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]·cleared 2021-03-04
K191976 — Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC·cleared 2019-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.