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 Power...
Summary BD Needle Kits for Powered Driver (in five sizes ranging from 15mm to 55mm) are recalled because the obturator may lock to the needle hub and become difficult or impossible to remove after insertion. This locking issue stems from parts that don't meet specifications and unclear instructions, which could delay treatment by requiring a new needle to be placed. The recall affects healthcare facilities across most U.S. states.
- Recalling firm
- Bard Access Systems, Inc.
- 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
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-30
- Status
- Ongoing
- Areas affected
- AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, ...
- 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
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/b7fcd03d-1676-4941-ae44-af22816fdc17