Z-2257-2026Class I

BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with...

Name: Z-2257-2026 BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with...
Creator: Becton Dickinson & Company
Published: 2026-04-27
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2026-04-27 / Open, Classified / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BDSpinal Tray with BDWhitacre 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... on 2026-04-27. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2257-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-04-27
Posted: 2026-05-29
Recalling firm: Becton Dickinson & Co
Product: BDSpinal Tray with BDWhitacre 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.
Product code: CAZ Anesthesia Conduction Kit
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 5,940 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.
Product codes and lots: 1. Catalog Number: 405637. UDI Numbers: (01)00382904056377(17)260628(10)B01V160D, (01)00382904056377(17)270101(10)B01V241D, (01)00382904056377(17)270101(10)B01V265D, (01)00382904056377(17)261001(10)B02V183D. Lot Numbers (Expiration Date): B01V160D (2026-06-28), B01V241D (2027-01-01), B01V265D (2027-01-01), B02V183D (2026-10-01). 2. Catalog Number: 405707. UDI Number: (01)00382904057077(17)270101(10)B02V230D. Lot Number (Expiration Date): B02V230D (2027-01-01).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2257-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2248-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2249-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2250-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2251-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2252-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2253-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2254-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2255-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2256-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2257-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29

Product code CAZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)