Becton Dickinson & Company: BDSpinal Tray with BDQuincke 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: 405621, 405735.

Recall number

Z-2249-2026

Recalling firm

Becton Dickinson & Company

Product

BDSpinal Tray with BDQuincke 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: 405621, 405735.

Status

Open, Classified

Initiated

2026-04-27

Posted

2026-05-29

Terminated

not on file

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.

Root 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. An updated notice was distributed to consignees on 7/8/26 clarifying recal

Quantity

3,130 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.

Lot, serial or model codes

1. Catalog Number: 405621. UDI Numbers: (01)00382904056216(17)260601(10)B01V142D, (01)00382904056216(17)260628(10)B01V176D. Lot Numbers (Expiration Date): B01V142D (2026-06-01), B01V176D (2026-06-28). 2. Catalog Number: 405735. UDI Numbers: (01)00382904057350(17)260601(10)B01V149D, (01)00382904057350(17)261001(10)B01V190D. Lot Numbers (Expiration Date): B01V149D (2026-06-01), B01V190D (2026-10-01).

510(k) numbers

not on file

PMA numbers

not on file

Product code

CAZ

Firm FEI

2243072

Firm city

Franklin Lakes

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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