The Recall Desk
SevereFDA (Devices)·Z-2254-2026·Announced 2026-06-10

BD Whitacre 25 gauge spinal trays recalled over bupivacaine quality issues

BD Spinal Trays with a Whitacre 25 G needle, catalog number 405658, are being recalled as a sub-recall of the Huons bupivacaine product recall. 150 units affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

The BD Spinal Tray with BD Whitacre Needle 25 G x 3.5 in, containing lidocaine HCl 1% (2 mL) and bupivacaine HCl 0.75% with dextrose 8.25% (2 mL), catalog number 405658, is being recalled. The action covers 150 units.

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. The FDA classified the action as Class I, its most serious classification.

Distribution was nationwide across a large number of states. The trays are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the catalog number, UDI number and lot numbers in the recall notice, quarantine it, and follow the instructions issued by BD.

The recalled product

Product
BD¿Spinal Tray with BD¿Whitacre 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.
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Spinal anesthesia tray
Hazard
  • contained-drug-recall
  • acceptance-testing
  • class-i
  • spinal-anesthesia

Distribution

Distributed nationwide across the United States.

Related recalls

Same category