Recall Z-2277-2026
B Braun Medical Inc · initiated May 6, 2026
Class I – dangerous or defective products that could cause serious health problems or death
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)
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;
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
On May 6, 2026, URGENT MEDICAL DEVICE RECALL were sent to customers. Actions to be taken: - Check inventory for affected product and return to B Braun. The return process will begin when B Braun received the Acknowledgement Form.) - If you are a distributor and have further distributed the product, please forward this notice to your consignees. This recall is to be extended to the hospital/healthcare facility level. Should there be any questions, comments, or concerns, please feel free to contact us via email at recalls@bbraunusa.com or via phone at 844-903-6417 Monday through Friday, 8:00am-5:00pm EST.
Details
- Recall number
- Z-2277-2026
- Initiated
- May 6, 2026
- Posted by FDA
- June 3, 2026
- Product code
- OFU – Spinal Anesthesia Kit
- Quantity
- 16,080 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- B Braun Medical Inc, Bethlehem, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2276-2026 Class I | Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL…These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the… | 05/06/2026Open, Classified |
| Z-2278-2026 Class I | Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description…These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the… | 05/06/2026Open, Classified |