Official recall notice
FDA DeviceClass INotable
FDA Recall: Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRA
- 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
582,030 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.