Design Options Spinal Tray Spinal Needle Anesthesia procedure kits:… — Class I medical device recall Z-2278-2026
Ongoing recall by B Braun Medical Inc, reported 2026-06-10, distributed nationwide. These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bup
| Recall number | Z-2278-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Bethlehem, PA, United States |
| Recall initiated | 2026-05-06 |
| Classified | 2026-06-03 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 104,720 units |
| UPC / GTIN / UDI-DI | 04046955331857, 04046955331864, 04046955595884, 04046955595891, 04046955595938, 04046955595945, 04046955595976, 04046955595983, 04046964317859, 04046964317873, 04046964318054, 04046964318061, 04046964318085, 04046964318108, 04046964318207, 04046964318221, 04046964318405, 04046964318429, 04046964318597, 04046964318610, 04046964318740, 04046964318764, 04046964318788, 04046964318801, 04046964318931 and 45 more |
| Lot numbers | 0061951279, 0061952176, 0061954111, 0061954114, 0061954120, 0061954147, 0061957394, 0061958133, 0061958137, 0061958142, 0061958274, 0061959460, 0061960367, 0061960383, 0061960420, 0061961001, 0061961002, 0061961836, 0061961847, 0061961853, 0061964747, 0061964879, 0061965746, 0061965762, 0061966001, 0061967077, 0061967078, 0061967083, 0061967090, 0061967991, 0061969404, 0061969405, 0061970744, 0061971283, 0061971284, 0061971285, 0061971287, 0061971288, 0061971313, 0061971321 and 39 more |
Product
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);
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2278-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.