Class 1 Device Recall BDSpinal Tray

• Date Initiated by Firm: April 27, 2026
• Date Posted: May 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2251-2026
• Recall Event ID: 98842
• Product Classification: Anesthesia conduction kit - Product Code CAZ
• Product: BDSpinal Tray with BDWhitacre 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.
• Code Information: Catalog Number: 405645. UDI Numbers: (01)00382904056452(17)261001(10)B01V223D. Lot Number (Expiration Date): B01V223D (2026-10-01).
• FEI Number: 2243072
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: 201-847-6800
• Manufacturer 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 Determined Cause: Nonconforming Material/Component
• Action: Becton Dickinson (BD) notified consignees via FedEx letter on about 04/27/2026. Customers were instructed to cease use of affected Bupivacaine ampules in the trays, secure an alternate local Bupivacaine drug prior to procedures, upon opening the kit, remove and destroy the affected Bupivacaine from the BD Anesthesia Tray, and if affected Bupivacaine was used with no issue there is no additional treatment or clinical follow up is needed, but if issues were encountered, report the incident per institutional guidelines and take any necessary actions. Additional instruction included to circulate the notification to applicable personnel or to any organizations where the potentially affected products have been transferred/distributed, post the notification on all inventory storage locations and any location where the product may be used, review recall letter BD received from Elevaris Medical Devices, and complete and return the provided Customer Response Form. Distributors were instructed to identify all affected inventory and attach the customer communication provided to each unit prior to distribution, identify customers within distribution network that purchased affected product, provide a copy of the customer letter to all customers to advise them of the field action notification on BD's behalf, circulate the notification to all applicable personnel, review recall letter BD received from Elevaris Medical Devices, and complete and return the provided Customer Response Form. BD has been made aware that the FDA has placed Bupivacaine manufactured by Huons Co., Ltd. on import alert #66-40 - Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs. Houns Co., Ltd. issued a product recall for its Bupivacaine ampules requesting quarantine of all ampules within expiry date. BD has ceased manufacturing kits/trays with the impacted Huons Co., Ltd Bupivacaine ampules.
• Quantity in Commerce: 330 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.