Spinal Needle procedure kits: 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)
FDA Recall Z-2276-2026 · Posted 2026-06-03
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Recalling FirmB Braun Medical Inc
Recall StatusOpen, Classified
Product CodeOFU
Date Initiated2026-05-06
Product Quantity582,030 units
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.
Firm Action
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 [email protected] or via phone at 844-903-6417 Monday through Friday, 8:00am-5:00pm EST.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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