BD Luer-Lok, BD Glaspak recallZ-2257-2026 · Becton Dickinson & Company · initiated Apr 27, 2026

Why it was recalled

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 root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number

Z-2257-2026

Status

Open, Classified

Initiated by the company

Apr 27, 2026

Posted by the FDA

May 29, 2026

Recalling firm

Becton Dickinson & Company

Quantity

5,940 units

Product code

CAZ

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 description

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• BD Luer-Lok, BD Glaspak 405637

  Becton, Dickinson And Company · Anesthesia conduction kit
  1 recall7 reports
• BD Luer-Lok, BD Glaspak 405707

  Becton, Dickinson And Company · Anesthesia conduction kit
  1 recall4 reports

Product lines

• BD Luer-Lok, BD GlaspakBecton, Dickinson And Company · 16 models · 141 reports · 8 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 98842).

• Z-2248-2026 · Open, Classified
  BDSpinal Tray with BDQuincke 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.
• Z-2249-2026 · Open, Classified
  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.
• Z-2250-2026 · Open, Classified
  BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.
• Z-2251-2026 · Open, Classified
  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.
• Z-2252-2026 · Open, Classified
  BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.
• Z-2253-2026 · Open, Classified
  BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Cata…
• Z-2254-2026 · Open, Classified
  BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.
• Z-2255-2026 · Open, Classified
  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: 400866, 405672, 4056…
• Z-2256-2026 · Open, Classified
  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 Number: 405671.