Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUT

FDA device recall Z-2278-2026 · posted 2026-06-03 · Open, Classified

Recall details

Recalling firm

B Braun Medical Inc

Reason for recall

A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OFU

Quantity affected

104,720 units

Distribution

US Nationwide distribution.

Date initiated

2026-05-06

Date posted

2026-06-03

Location

Bethlehem, PA