Becton Dickinson & Company: Anesthesia Conduction Kit

Recall Summary Becton Dickinson is recalling BD Spinal Tray anesthesia kits (catalog number 405658) that contain bupivacaine solution due to quality control deficiencies found during an FDA inspection of the bupivacaine manufacturer, Huons Co, Ltd. The kits were distributed nationwide to hospitals and medical facilities. This is a Class II recall, meaning the product could cause adverse health effects but serious injury or death is not likely.

Recalling firm
Becton Dickinson & Company
Product
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.
Reason
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.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-04-27
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/07899037-2ae9-4d88-a047-7831fd86c033