BD Needle Kit for Powered Driver Recall Issued

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Bard Access Systems, Inc. is recalling 80,200 units of BD Needle Kits for Powered Driver due to potential difficulty removing the obturator, which may delay therapy.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class I recall, with the stated 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", distributed 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 recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.

What Happened

Bard Access Systems, Inc. initiated a voluntary Class I recall of BD Needle Kits for Powered Driver after placement of intraosseous (IO) needle sets. Users may experience difficulty or inability to remove the obturator due to it locking to the needle hub from out-of-tolerance dimensions and IFU unclarity. This may result in new needle placement and delayed therapy.

Which Products Are Affected

The recall affects 80,200 units of the following products distributed in US states including 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 and OUS locations CA, SG:

  • 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

Specific lot numbers and expiration dates are listed under recall number Z-2872-2026.

What You Should Do

The recall is ongoing. Users should be aware of the potential for delayed therapy when using affected devices in emergent, urgent, or medically necessary cases.

Why This Matters

The Class I recall involves devices used when intravenous access is difficult or impossible to obtain, where any delay in therapy could impact patient care.

Source

FDA recall number Z-2872-2026, Event ID 99484.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Bard Access Systems, Inc. is recalling 80,200 units of BD Needle Kits for Powered Driver due to potential difficulty removing the obturator, which may delay therapy.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class I recall, citing "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" as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.