Recall Z-2257-2026— Becton Dickinson & Company
Class I · Ongoing
Class I FDA medical device recall by Becton Dickinson & Company, initiated 2026-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.. 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..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-04-27
- Firm location
- Franklin Lakes, NJ, United States
Product description
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.