B Braun Medical Inc: Design Options Spinal Tray Material Description (material Number): Ssk Hackensack Medical Ctr 20061890 (560074), Ssk Sutter Community Hospital (560...
Recall Summary B. Braun Medical Inc is recalling Design Options Spinal Trays distributed nationwide to hospitals and medical centers because they contain Bupivacaine Hydrochloride in Dextrose Injection from manufacturer Huons Co, Ltd., which has been recalled due to potential quality issues. This is a Class I recall, the most serious classification. The affected trays were distributed to numerous hospitals across all U.S. states and territories.
- Recalling firm
- B Braun Medical Inc
- Product
- Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUTTER COMMUNITY HOSPITAL (560214), SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), SSK TORRANCE MEMORIAL HOSPITAL (560394), SSK SURGERY ONE 20070208 (560428), SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), SSK HOAG MEMORIAL HOSPITAL (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK KAISER FOUNDATION HOSPITAL (560497), SSK THOMAS JEFFERSON UNIV HOSP (560513), SSK OVERLAKE MEDICAL CENTER (560521), SSK CUSTOM SPINAL...
- 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 I
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/acc84a25-190c-4e90-9562-f7b3b0dea871