B Braun Medical Inc recalls Spinocan Spinal Needle procedure kits: Material Description

Recalling company

B Braun Medical Inc

Product

Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231)

Reason

These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

May 6, 2026

Reported

Jun 10, 2026

Distribution

US Nationwide distribution.

Status

Ongoing

Quantity

16,080 units

Lot / codes

1. Material: 333201; UDI-DI Primary/Unit of Use: 4046964179365/4046964179358; Batch Number: 0061976152; 2. Material: 333211; UDI-DI Primary/Unit of Use: 4046964179389/4046964179372; Batch numbers: 0061965729, 0061971323, 0061972572; 3. Material: 333231; UDI-DI Primary/Unit of Use: 4046964179488/4046964179471; Batch Number: 0061978177;

Company location

Bethlehem, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-2277-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2277-2026 in the FDA Enforcement Report. Also see FDA recall press releases.