Notice names this product. B Braun Medical’s Design Options Spinal Tray Spinal Needle Anesthesia procedure kits is named in FDA Class I recall Z-2278-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: 1. 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;. Units affected: 104,720 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
- Product named
- Design Options Spinal Tray Spinal Needle Anesthesia procedure kits
- Company / brand
- B Braun Medical
- Lot / serial / date codes
- 1. 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;
- Distribution
- US Nationwide distribution.
Agency product description and boundaries
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);
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
FDA Class I · Medical device · June 10, 2026
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 potenti…
Company / brand: B Braun Medical recalls
Affected product: Design Options Spinal Tray Spinal Needle Anesthesia procedure kits recall status
Official ID Z-2278-2026 ·
Official record ↗
Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.