FDA-Device2026-08-26Class IPROCESSING DEFECT

BD Needle Kit for Powered Driver recalled for obturator locking risk

What this means

BD Needle Kits used for emergency intraosseous (IO) access may have an obturator (the needle's internal plunger) that locks to the needle hub and becomes difficult or impossible to remove after placement. This locking is caused by out-of-tolerance manufacturing dimensions. If the obturator cannot be removed, a new needle may need to be placed, potentially delaying treatment.

  • Check your inventory for the affected needle kit models and lot numbers listed in the recall notice.
  • Do not use affected kits for new procedures; contact BD or your distributor for replacement stock.
  • If an obturator locks after needle placement, follow your facility's protocols for safe removal and secondary access placement.
  • Report any obturator locking incidents to BD and the FDA MedWatch program.
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The agency's original wording
Hazard

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

Intended for
Adults
Illnesses reported
None reported
Sold states
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
Affected count
80,200
Manufactured in
605 N 5600 W, Salt Lake City, UT, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2872-2026

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