FDAFDA · Food and drugs·Recall number Z-2251-2026
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.
Published June 10, 2026 · Recall initiated: April 27, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Company
- Distributor
- 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.
- Lot
- Catalog Number: 405645. UDI Numbers: (01)00382904056452(17)261001(10)B01V223D. Lot Number (Expiration Date): B01V223D (2026-10-01).
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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