Recall Z-2872-2026 ยท FMI Needle, Hypodermic, Single Lumen
Bard Access Systems, Inc.
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
| Date | Aug 14, 2026 (initiated Jul 30, 2026) |
| Status | Open, Classified |
| 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 |
| Root cause | Component change control |
| Action | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |