Z-2872-2026Class I

Bard Access Systems, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-08-26

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

Firm state

Product quantity

80,200

Initiated by

Voluntary: Firm initiated

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

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

Code / lot info

REF/UDI-DI/Lot(Expiration): D015151NK/00801741163586/BSLC9275(2026-08-03), BSLC9563(2026-08-13), BSLC9567(2026-08-25), BSLC10103(2026-09-27), BSLC10516(2026-11-01), BSLC10526(2026-11-16), BSLC10872(2026-12-09), BSLC11216(2028-07-02), BSLC11456(2028-07-23); D015251NK/00801741163678/BSLC9467(2026-08-10), BSLC9575(2026-09-20), BSLC10105(2026-10-04), BSLC10522(2026-11-07), BSLC10868(2026-12-02), BSLC11212(2028-06-18), BSLC11454(2028-07-17), BSLC11463(2028-08-07), BSLC11884(2028-09-15), BSLC11890(2028-09-18), BSLC12082(2028-10-08), BSLC12115(2028-10-20), BSLC12123(2028-10-22); D015351NK/00801741163593/BSLC11458(2028-07-24); 00801741163678/BSLC9277(2026-08-04), BSLC9485(2026-08-12), BSLC9569(2026-08-26), BSLC10099(2026-09-07), BSLC10514(2026-10-16), BSLC10518(2026-10-21), BSLC10524(2026-11-08), BSLC10870(2026-12-03), BSLC10874(2028-06-12), BSLC11218(2028-07-07); D015451NK/00801741163609/BSLC9279(2026-08-06), BSLC9565(2026-08-17), BSLC9571(2026-09-07), BSLC10101(2026-09-17), BSLC10456(2026-10-14), BSLC10520(2026-10-22), BSLC10866(2026-11-21), BSLC11214(2028-06-23), BSLC11450(2028-07-09), BSLC11460(2028-07-31), BSLC11873(2028-08-13), BSLC11888(2028-09-25), BSLC12007(2028-10-02), BSLC12105(2028-10-15); D015551NK/00801741163616/BSLC9465(2026-08-07), BSLC9573(2026-09-26), BSLC10107(2026-10-02), BSLC10528(2026-11-20), BSLC11452(2028-07-10)

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →