FDAClass I · Medical device · Recalled June 10, 2026

BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3 recall — Becton Dickinson & Company

Hazard: This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2251-2026
Brand: Becton Dickinson & Company
Classification: Class I
Units affected: 330 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3

Companies & origin

Recalling firm location: Franklin Lakes, NJ, United States
Firm address: 1 Becton Dr, 07417-1815

Identifying details (verbatim from the notice)

Product codes / lots: Catalog Number: 405645. UDI Numbers: (01)00382904056452(17)261001(10)B01V223D. Lot Number (Expiration Date): B01V223D (2026-10-01).
Distribution: Nationwide distribution to 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.
Firm notified the public via: Letter
FDA event ID: 98842
Recall initiated: April 27, 2026
FDA classified: May 29, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

Report a data error on this page