BD Spinal Tray Recall Issued by Becton Dickinson

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.

Becton Dickinson & Company is recalling 330 units of BD Spinal Tray with BD Whitacre Needle (Catalog 405645) nationwide due to quality issues with the bupivacaine component.

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

This notice was issued by FDA on July 11, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. 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, medical-devices.

What Happened

Becton Dickinson & Company initiated a voluntary recall of the BD Spinal Tray after a sub-recall from manufacturer Huons Co, Ltd. The action stems from quality deficiencies related to acceptance testing identified during an FDA inspection of the bupivacaine manufacturing facility.

Which Products Are Affected

  • Product: BD Spinal Tray with BD Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine)
  • Catalog Number: 405645
  • Lot Number: B01V223D (Expiration Date: 2026-10-01)
  • UDI: (01)00382904056452(17)261001(10)B01V223D
  • Quantity: 330 units
  • Distribution: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY)
  • Recall Number: Z-2251-2026
  • Classification: Class I

What You Should Do

Consumers and healthcare providers should contact Becton Dickinson & Company regarding the recalled product.

Why This Matters

This Class I recall indicates a reasonable probability of serious adverse health consequences from the affected spinal trays distributed across the United States.

Source

FDA recall Z-2251-2026, Becton Dickinson & Company, Franklin Lakes, NJ

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?
Becton Dickinson & Company is recalling 330 units of BD Spinal Tray with BD Whitacre Needle (Catalog 405645) nationwide due to quality issues with the bupivacaine component.
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 severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
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.