{"url_path":"/fda/device/recalls/Z-2278-2026","section_key":"summary","section_title":"DEVICE Recall: B Braun Medical Inc — 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 BUPIVACAIN…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-06","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2278-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"B Braun Medical Inc"},"word_count":750,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2278-2026\n\n**Recalling firm:** B Braun Medical Inc\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-06\n**Report date:** 2026-06-10\n\n## Product\nDesign 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);\n\n## Reason\nThese procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.\n\n## Affected lots\n1. Material: 560074; UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859; Batch Numbers: 0061960383, 0061972565; 2. Material: 560214; UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054; Batch Numbers: 0061971346, 0061977782; 3. Material: 560272; UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085; Batch Numbers: 0061960367, 0061971330; 4. Material: 560327; UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207; Batch Numbers: 0061960420, 0061977751; 5. Material: 560394; UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405; Batch Numbers: 0061964747, 0061976985, 0061983313; 6. Material: 560428; UDI-DI Primary/Individual Unit of Use: 04046964318610/04046964318597; Batch Numbers: 0061976150, 0061979927; 7. Material: 560462; UDI-DI Primary/Individual Unit of Use: 04046964318764/04046964318740; Batch Number: 0061977772; 8. Material: 560465; UDI-DI Primary/Individual Unit of Use: 04046964318801/04046964318788; Batch Numbers: 0061976120, 0061976122, 0062024615; 9. Material: 560476; UDI-DI Primary/Individual Unit of Use: 04046964318948/04046964318931; Batch Numbers: 0061964879, 0061977776, 0061985361; 10. Material: 560497; UDI-DI Primary/Individual Unit of Use: 04046964319136/04046964319112; Batch Numbers: 0061967077, 0061985362; 11. Material: 560513; UDI-DI Primary/Individual Unit of Use: 04046964319273/04046964319259; Batch Numbers: 0061961836, 0061977766; 12. Material: 560521; UDI-DI Primary/Individual Unit of Use: 04046964319440/04046964319426; Batch Numbers: 0061967083, 0061977226; 13. Material: 560523; UDI-DI Primary/Individual Unit of Use: 04046964319471/04046964319457; Batch Numbers: 0061952176, 0061971321; 14. Material: 560533; UDI-DI Primary/Individual Unit of Use: 04046964319518/04046964319495; Batch Numbers: 0061954120, 0061971287, 0061971288; 15. Material: 560538; UDI-DI Primary/Individual Unit of Use: 04046964319587/04046964319563; Batch Numbers: 0061971325, 0061973771; 16. Material: 560572; UDI-DI Primary/Individual Unit of Use: 04046964319990/04046964319976; Batch Number: 0061961001; 17. Material: 560580; UDI-DI Primary/Individual Unit of Use: 04046964320194/04046964320170; Batch Number: 0061967090; 18. Material: 560584; UDI-DI Primary/Individual Unit of Use: 04046964320293/04046964320286; Batch Number: 0061961847; 19. Material: 560587; UDI-DI Primary/Individual Unit of Use: 04046964320408/04046964320378; Batch Number: 0061972579; 20. Material: 560603; UDI-DI Primary/Individual Unit of Use: 04046964320842/04046964320828; Batch Numbers: 0061951279, 0061954147, 0061958274, 0061969404, 0061969405, 0061970744, 0061974805; 21. Material: 560606; UDI-DI Primary/Individual Unit of Use: 04046964320958/04046964320927; Batch Numbers: 0061965746, 0061965762, 0061971283, 0061971284, 0061971285; 22. Material: 560607; UDI-DI Primary/Individual Unit of Use: 04046964320989/04046964320965; Batch Numbers: 0061958137, 0061972577, 0061985364; 23. Material: 560609; UDI-DI Primary/Individual Unit of Use: 04046964321047/04046964321030; Batch Numbers: 0061958142, 0061975207, 0061985374; 24. Material: 560613; UDI-DI Primary/Individual Unit of Use: 04046964321153/04046964321146; Batch Number: 0061972578; 25. Material: 560619; UDI-DI Primary/Individual Unit of Use: 04046964321306/04046964321290; Batch Numbers: 0061954114, 0061971313; 26. Material: 560621; UDI-DI Primary/Individual Unit of Use: 04046964321375/04046964321368; Batch Numbers: 0061961853, 0061976112, 0061977798;  27. Material: 560628; UDI-DI Primary/Individual Unit of Use: 04046964526749/04046964526732; Batch Numbers: 0061954111, 0061959460; 28. Material: 560645; UDI-DI Primary/Individual Unit of Use: 04046964809088/04046964809071; Batch Numbers: 0061967991, 0061977778; 29. Material: 560646; UDI-DI Primary/Individual Unit of Use: 04046964809101/04046964809095; Batch Number: 0061957394; 30. Material: 560647; UDI-DI Primary/Individual Unit of Use: 04046964809125/04046964809118; Batch Numbers: 0061971336, 0061977571, 0061985370; 31. Material: 560648; UDI-DI Primary/Individual Unit of Use: 04046964809149/04046964809132; Batch Numbers: 0061961002, 0061977800, 0061977801;  32. Material: 560660; UDI-DI Primary/Individual Unit of Use: 04046955331864/04046955331857; Batch Number: 0061958133; 33. Material: 560667; UDI-DI Primary/Individual Unit of Use: 04046955595891/04046955595884; Batch Numbers: 0061966001, 0061976124, 0061977803; 34. Material: 560670; UDI-DI Primary/Individual Unit of Use: 04046955595945/04046955595938; Batch Number: 0061972569; 35. Material: 560672; UDI-DI Primary/Individual Unit of Use: 04046955595983/04046955595976; Batch Numbers: 0061967078, 0061977783;\n\n## Distribution\nUS Nationwide distribution."}