Bard Access Systems, Inc.: Needle, Hypodermic, Single Lumen
Bard Access Systems is recalling five models of BD Needle Kits for Powered Driver used to place intraosseous needles (emergency access to bone marrow when veins cannot be accessed) because the obturator may lock to the needle hub and become difficult or impossible to remove due to manufacturing tolerances and unclear instructions. This locking issue may require placement of a new needle and delay emergency treatment. The recall affects products distributed across most U.S. states and in Canada and Singapore.
- 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 II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-30
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ce60e819-385a-4069-9f61-344728cc9fbe