Becton Dickinson & Company: Anesthesia Conduction Kit

Becton Dickinson is recalling anesthesia kits (catalog numbers 400868 and 405652) that contain bupivacaine solution due to quality issues found during an FDA inspection of the component manufacturer. The kits were distributed nationwide and are used for spinal anesthesia procedures. This is a Class II recall, meaning the product could cause adverse health effects but is unlikely to cause serious injury.

Recalling firm
Becton Dickinson & Company
Product
BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.
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/53249d1e-8296-4c81-ad53-cb79062fa360