Official recall notice
FDA DeviceClass INotable
FDA Recall: Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material
- 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
104,720 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.