Official recall notice
FDA DeviceClass INotable
FDA Recall: Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x
- Recall date
- 2026-06-10
- Brand
- B Braun Medical Inc
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
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.
Recommended action
What to do
16,080 units
Product description
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.