Critical Alert
Becton Dickinson & Company Recalls BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2248-2026Medical Device
Becton Dickinson & Company Recalls BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5
Becton Dickinson & Company · Class I — Most Serious
Product Description
BD¿Spinal Tray with BD¿Quincke 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: 405609.
Reason for Recall
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.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Becton Dickinson & Company is recalling a medical device classified as Class I by the FDA — the highest risk level. The recall was initiated on April 27, 2026 affecting 990 units. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. It was distributed nationwide. Consumers and healthcare professionals should exercise caution and discontinue use of the recalled product. Contact the recalling firm directly for return or disposal instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.