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High risk Medical DevicesClass I

BD Spinal Tray Whitacre Needle 405645 Recall

BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcai

Updated April 27, 2026

Becton Dickinson is recalling a spinal anesthesia tray because one of its drug components, bupivacaine hydrochloride in dextrose injection, was made at a facility with quality deficiencies found during an FDA inspection. Patients who received spinal anesthesia using this tray may have been given a drug that did not meet required quality standards.

Is the Becton Dickinson & Company recalled? Yes. This product was recalled by FDA on April 27, 2026. Details below.

What is recalled

BD Spinal Tray with BD Whitacre Needle, 22 G x 3.5 in., containing lidocaine HCL (1%), 5 mL, and bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645. Manufactured by Becton Dickinson and Company.

Am I affected

You may be affected if you received spinal anesthesia using a BD Spinal Tray with catalog number 405645. This product is used by healthcare providers, not purchased directly by consumers. If you had a procedure involving spinal anesthesia and want to know whether this tray was used, contact your hospital or healthcare provider.

What to do right now

If you are a healthcare provider or facility, stop using catalog number 405645 and follow your institution's recall response procedures. If you are a patient who received this product and have concerns, contact your doctor. No consumer contact number was provided by the firm; visit the FDA recall page at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts for updates.

The hazard

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.

Brands affected

Becton Dickinson & Company
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2251-2026
Classification
Class I
Recalled
April 27, 2026
Read the official notice

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