- 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
- Affected products (lot / model / serial)
- 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)
- Units affected
- 80,200
- Distribution pattern
- 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 location
- Salt Lake City, UT, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2872-2026
- Recall initiated
- July 30, 2026
- FDA classification date
- August 14, 2026
- FDA report date
- August 26, 2026
- FDA event ID
- 99484
- Last updated on HTM Vibe
- September 8, 2026