B Braun Medical Inc: Spinal Anesthesia Kit

Recall Summary B. Braun Medical Inc. is recalling Spinocan spinal anesthesia kits in three needle gauges (22, 25, and 26 gauge) that contain Bupivacaine 0.75% with Dextrose 8.25% due to potential quality issues with the Bupivacaine component supplied by manufacturer Huons Co, Ltd. The kits have been distributed nationwide to hospitals and medical facilities across all U.S. states. This is a Class II recall, meaning the product could cause adverse health effects but is unlikely to cause serious injury.

Recalling firm: B Braun Medical Inc
Product: Spinocan 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);
Reason: 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.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-05-06
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: US Nationwide distribution.

Recall details on Nibble Recalls: https://trynibble.app/recalls/362f9f81-01aa-4908-907e-e7cb36c7d246