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 C
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.
- Agency
- FDA Device
- Recall date
- May 6, 2026
- Status
- Ongoing
- Company
- B Braun Medical Inc
1. What product was recalled?
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 C
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);
Quantity: 104,720 units
Code or lot text: 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;
- LOT
- 0061954147
- LOT
- 0061958274
- LOT
- 0061959460
- LOT
- 0061965762
- LOT
- 0061969404
- LOT
- 0061969405
- LOT
- 0061970744
- LOT
- 0061971283
- LOT
- 0061971284
- LOT
- 0061971285
- LOT
- 0061971287
- LOT
- 0061971288
- LOT
- 0061971313
- LOT
- 0061971321
- LOT
- 0061971330
- LOT
- 0061972565
- LOT
- 0061972577
- LOT
- 0061973771
- LOT
- 0061974805
- LOT
- 0061975207
- LOT
- 0061976112
- LOT
- 0061976122
- LOT
- 0061976124
- LOT
- 0061976985
- LOT
- 0061977226
- LOT
- 0061977571
- LOT
- 0061977751
- LOT
- 0061977766
- LOT
- 0061977776
- LOT
- 0061977778
- LOT
- 0061977782
- LOT
- 0061977783
- LOT
- 0061977798
- LOT
- 0061977800
- LOT
- 0061977801
- LOT
- 0061977803
- LOT
- 0061979927
- LOT
- 0061983313
- LOT
- 0061985361
- LOT
- 0061985362
- LOT
- 0061985364
- LOT
- 0061985370
- LOT
- 0061985374
- LOT
- 0062024615
- LOT
- 1. Material: 560074
- LOT
- 10. Material: 560497
- LOT
- 11. Material: 560513
- LOT
- 12. Material: 560521
- LOT
- 13. Material: 560523
- LOT
- 14. Material: 560533
- LOT
- 15. Material: 560538
- LOT
- 16. Material: 560572
- LOT
- 17. Material: 560580
- LOT
- 18. Material: 560584
- LOT
- 19. Material: 560587
- LOT
- 2. Material: 560214
- LOT
- 20. Material: 560603
- LOT
- 21. Material: 560606
- LOT
- 22. Material: 560607
- LOT
- 23. Material: 560609
- LOT
- 24. Material: 560613
- LOT
- 25. Material: 560619
- LOT
- 26. Material: 560621
- LOT
- 27. Material: 560628
- LOT
- 28. Material: 560645
- LOT
- 29. Material: 560646
- LOT
- 3. Material: 560272
- LOT
- 30. Material: 560647
- LOT
- 31. Material: 560648
- LOT
- 32. Material: 560660
- LOT
- 33. Material: 560667
- LOT
- 34. Material: 560670
- LOT
- 35. Material: 560672
- LOT
- 4. Material: 560327
- LOT
- 5. Material: 560394
- LOT
- 6. Material: 560428
- LOT
- 7. Material: 560462
- LOT
- 8. Material: 560465
- LOT
- 9. Material: 560476
- LOT
- Batch Number: 0061957394
- LOT
- Batch Number: 0061958133
- LOT
- Batch Number: 0061961001
- LOT
- Batch Number: 0061961847
- LOT
- Batch Number: 0061967090
- LOT
- Batch Number: 0061972569
- LOT
- Batch Number: 0061972578
- LOT
- Batch Number: 0061972579
- LOT
- Batch Number: 0061977772
- LOT
- Batch Numbers: 0061951279
- LOT
- Batch Numbers: 0061952176
- LOT
- Batch Numbers: 0061954111
- LOT
- Batch Numbers: 0061954114
- LOT
- Batch Numbers: 0061954120
- LOT
- Batch Numbers: 0061958137
- LOT
- Batch Numbers: 0061958142
- LOT
- Batch Numbers: 0061960367
- LOT
- Batch Numbers: 0061960383
- LOT
- Batch Numbers: 0061960420
- LOT
- Batch Numbers: 0061961002
- LOT
- Batch Numbers: 0061961836
- LOT
- Batch Numbers: 0061961853
- LOT
- Batch Numbers: 0061964747
- LOT
- Batch Numbers: 0061964879
- LOT
- Batch Numbers: 0061965746
- LOT
- Batch Numbers: 0061966001
- LOT
- Batch Numbers: 0061967077
- LOT
- Batch Numbers: 0061967078
- LOT
- Batch Numbers: 0061967083
- LOT
- Batch Numbers: 0061967991
- LOT
- Batch Numbers: 0061971325
- LOT
- Batch Numbers: 0061971336
- LOT
- Batch Numbers: 0061971346
- LOT
- Batch Numbers: 0061976120
- LOT
- Batch Numbers: 0061976150
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046955331864/04046955331857
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046955595891/04046955595884
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046955595945/04046955595938
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046955595983/04046955595976
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964318610/04046964318597
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964318764/04046964318740
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964318801/04046964318788
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964318948/04046964318931
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964319136/04046964319112
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964319273/04046964319259
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964319440/04046964319426
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964319471/04046964319457
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964319518/04046964319495
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964319587/04046964319563
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964319990/04046964319976
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964320194/04046964320170
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964320293/04046964320286
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964320408/04046964320378
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964320842/04046964320828
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964320958/04046964320927
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964320989/04046964320965
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964321047/04046964321030
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964321153/04046964321146
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964321306/04046964321290
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964321375/04046964321368
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964526749/04046964526732
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964809088/04046964809071
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964809101/04046964809095
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964809125/04046964809118
- LOT
- UDI-DI Primary/Individual Unit of Use: 04046964809149/04046964809132
- RECALL-NUMBER
- Z-2278-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the 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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
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10. Where is the official source?
Open the official FDA Device source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.