Agency classClass IOur severity:Severe FDA (Devices)·Z-2257-2026·Announced 2026-06-10

BD Whitacre 25G spinal trays recalled in Huons bupivacaine sub-recall

BD Spinal Trays with Whitacre needle 25 G, catalog numbers 405637 and 405707, are being recalled as a sub-recall of the Huons bupivacaine product recall. 5,940 units are affected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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% (5 mL) and bupivacaine HCl 0.75% with dextrose 8.25% (2 mL), catalog numbers 405637 and 405707, is being recalled. The action covers 5,940 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 numbers, UDI codes 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%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Spinal anesthesia tray
Hazard: contained-drug-recall
acceptance-testing
class-i
spinal-anesthesia
Affected units: 5,940

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

1. Catalog Number: 405637. UDI Numbers: (01)00382904056377(17)260628(10)B01V160D
(01)00382904056377(17)270101(10)B01V241D
(01)00382904056377(17)270101(10)B01V265D
B01V241D (2027-01-01)
B01V265D (2027-01-01)

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · Becton Dickinson & Company

See all →

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BD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
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BD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
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BD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
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BD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10

Same hazard · contained drug recall