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Open, Classified

Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672);

FDA Recall Z-2278-2026 · Posted 2026-06-03

Recalling FirmB Braun Medical Inc
Recall StatusOpen, Classified
Product CodeOFU
Date Initiated2026-05-06
Product Quantity104,720 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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