FreshRecalls

FDAClass I · Medical device · Recalled June 10, 2026

Spinocan Spinal Needle procedure kits recall — B Braun Medical Inc

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

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2277-2026
Brand
B Braun Medical
Classification
Class I
Units affected
16,080 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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)

Affected products

Companies & origin

Recalling firm location
Bethlehem, PA, United States
Firm address
824 12th Ave, 18018-3524

Identifying details (verbatim from the notice)

Product codes / lots
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;
Distribution
US Nationwide distribution.
FDA event ID
98838
Recall initiated
May 6, 2026
FDA classified
June 3, 2026
FDA report date
June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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