B Braun Medical Inc: Spinal Anesthesia Kit
Recall Summary B Braun Medical Inc is recalling several spinal anesthesia kits nationwide because the bupivacaine solution inside them—made by Huons Co, Ltd.—may have quality issues. These kits were distributed across all U.S. states and are used during spinal anesthesia procedures. The recall is classified as Class II, meaning there is potential for serious adverse health consequences.
- Recalling firm
- B Braun Medical Inc
- Product
- Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851);
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/807ed78d-557d-4ee5-8607-5726e951f597