FDA recall, , High risk
B. Braun Spinal Needle Procedure Kits
Spinal Needle procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP, with potential quality issues.
Summary by Recall Canary from the FDA notice
What happened
B. Braun Medical Inc, of Bethlehem, Pennsylvania, is recalling Spinocan Spinal Needle procedure kits, Spinal Needle procedure kits, and Design Options Spinal Tray Spinal Needle Anesthesia procedure kits.
The kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP, which the manufacturer, Huons Co, Ltd., voluntarily recalled due to potential quality issues identified during a recent FDA manufacturing facility inspection. The recall began May 6, 2026, and was added to the FDA's Enforcement Report on June 3, 2026.
The products were distributed nationwide in the United States. The recall affects the kits listed in the FDA's report, which include various material numbers for each product type.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Incomplete list: 80 of 230 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Spinocan Spinal Needle procedure kits
- UDI-DI
- 4046964179365
- 4046964179358
- 0061976152
- 4046964179389
- 4046964179372
- 0061965729
- 0061971323
- 0061972572
- 4046964179488
- 4046964179471
- 0061978177
Spinal Needle procedure kits
- UDI-DI
- 4046964180842
- 4046964180835
- 0061965993
- 0061968406
- 0061971306
- 0061971487
- 0061978629
- 0061978630
- 4046964180743
- 4046964180736
- 0061947858
- 0061954126
- 0061970779
- 0061970781
- 0061970783
- 4046964558757
- 4046964558740
- 0061976109
- 4046964180866
- 4046964180859
- 0061958120
- 0061958276
- 0061960474
- 0061960475
- 0061960476
- 0061960477
- 0061960478
- 0061965732
- 0061965733
- 0061965734
- 0061965735
- 0061965736
- 0061965737
- 0061965738
- 0061965739
- 0061965740
- 0061965741
- 0061965743
- 0061969393
- 0061969394
- 0061969395
- 0061969397
- 0061969438
- 0061969439
- 0061969440
- 0061969441
- 0061970674
- 0061970675
- 0061970726
- 0061970727
- 0061970729
- 0061970730
- 0061971108
- 0061975011
- 0061975012
- 0061975013
- 0061975014
- 0061975015
- 0061975016
- 0061975017
- 0061975018
- 0061976996
- 0061976997
- 0061976998
- 0061976999
- 0061979852
- 4046964180804
- 4046964180798
- 0061952152
- 0061964964
- 0061968295
- 4046964180903
- 4046964180897
- 0061954099
- 4046964180606
- 4046964180590
- 0061954106
- 0061954107
- 0061954108
- 0061954123
- 0061954124
- 0061954125
- 0061954130
- 0061954131
- 0061954132
- 0061954134
- 0061954135
- 0061960457
- 0061960458
- 0061960459
- 0061960460
- 0061960461
- 0061965687
- 0061965688
- 0061965689
- 0061967621
- 0061967623
- 0061967624
- 0061967626
- 0061969508
- 0061969986
- 0061970102
- 0061970104
- 0061970105
- 0061970106
- 0061970107
- 0061970109
- 0061970110
- 0061970860
- 0061970861
- 0061970863
- 0061970864
- 0061970866
- 0061970867
- 0061971261
- 0061971262
- 0061971263
- 0061971264
- 0061971265
- 0061971266
- 0061971268
- 0061971269
- 0061972812
- 0061972813
- 0061974198
- 0061974199
- 0061974200
- 0061974201
- 0061974247
- 0061974248
- 0061974249
- 0061974250
- 0061974251
- 0061974253
- 0061974559
- 0061974562
- 0061974563
- 0061974564
- 0061974569
- 0061975004
- 0061975005
- 0061975006
- 0061975007
- 0061975008
- 0061975009
- 0061975810
- 0061976903
- 0061976904
- 0061976905
- 0061976906
- 0061976908
- 0061976909
- 0061976910
- 0061976911
- 0061976912
- 0061976913
- 0061976914
- 0061976915
- 0061979785
- 0061979786
- 0061979787
- 0061979788
- 0061979790
- 0061979791
- 0062019490
- Lot code
- 0061965993
- 0061968406
- 0061971306
- 0061971487
- 0061978629
- 0061978630
- 0061947858
- 0061954126
- 0061970779
- 0061970781
- 0061970783
- 0061976109
- 0061958120
- 0061958276
- 0061960474
- 0061960475
- 0061960476
- 0061960477
- 0061960478
- 0061965732
- 0061965733
- 0061965734
- 0061965735
- 0061965736
- 0061965737
- 0061965738
- 0061965739
- 0061965740
- 0061965741
- 0061965743
- 0061969393
- 0061969394
- 0061969395
- 0061969397
- 0061969438
- 0061969439
- 0061969440
- 0061969441
- 0061970674
- 0061970675
Product details
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);
- UDI-DI
- 04046964317873
- 04046964317859
- 0061960383
- 0061972565
- 04046964318061
- 04046964318054
- 0061971346
- 0061977782
- 04046964318108
- 04046964318085
- 0061960367
- 0061971330
- 04046964318221
- 04046964318207
- 0061960420
- 0061977751
- 04046964318429
- 04046964318405
- 0061964747
- 0061976985
- 0061983313
- 04046964318610
- 04046964318597
- 0061976150
- 0061979927
- 04046964318764
- 04046964318740
- 0061977772
- 04046964318801
- 04046964318788
- 0061976120
- 0061976122
- 0062024615
- 04046964318948
- 04046964318931
- 0061964879
- 0061977776
- 0061985361
- 04046964319136
- 04046964319112
- 0061967077
- 0061985362
- 04046964319273
- 04046964319259
- 0061961836
- 0061977766
- 04046964319440
- 04046964319426
- 0061967083
- 0061977226
- 04046964319471
- 04046964319457
- 0061952176
- 0061971321
- 04046964319518
- 04046964319495
- 0061954120
- 0061971287
- 0061971288
- 04046964319587
- 04046964319563
- 0061971325
- 0061973771
- 04046964319990
- 04046964319976
- 0061961001
- 04046964320194
- 04046964320170
- 0061967090
- 04046964320293
- 04046964320286
- 0061961847
- 04046964320408
- 04046964320378
- 0061972579
- 04046964320842
- 04046964320828
- 0061951279
- 0061954147
- 0061958274
- 0061969404
- 0061969405
- 0061970744
- 0061974805
- 04046964320958
- 04046964320927
- 0061965746
- 0061965762
- 0061971283
- 0061971284
- 0061971285
- 04046964320989
- 04046964320965
- 0061958137
- 0061972577
- 0061985364
- 04046964321047
- 04046964321030
- 0061958142
- 0061975207
- 0061985374
- 04046964321153
- 04046964321146
- 0061972578
- 04046964321306
- 04046964321290
- 0061954114
- 0061971313
- 04046964321375
- 04046964321368
- 0061961853
- 0061976112
- 0061977798
- 04046964526749
- 04046964526732
- 0061954111
- 0061959460
- 04046964809088
- 04046964809071
- 0061967991
- 0061977778
- 04046964809101
- 04046964809095
- 0061957394
- 04046964809125
- 04046964809118
- 0061971336
- 0061977571
- 0061985370
- 04046964809149
- 04046964809132
- 0061961002
- 0061977800
- 0061977801
- 04046955331864
- 04046955331857
- 0061958133
- 04046955595891
- 04046955595884
- 0061966001
- 0061976124
- 0061977803
- 04046955595945
- 04046955595938
- 0061972569
- 04046955595983
- 04046955595976
- 0061967078
- 0061977783
- Lot code
- 0061960383
- 0061972565
- 0061971346
- 0061977782
- 0061960367
- 0061971330
- 0061960420
- 0061977751
- 0061964747
- 0061976985
- 0061983313
- 0061976150
- 0061979927
- 0061977772
- 0061976120
- 0061976122
- 0062024615
- 0061964879
- 0061977776
- 0061985361
- 0061967077
- 0061985362
- 0061961836
- 0061977766
- 0061967083
- 0061977226
- 0061952176
- 0061971321
- 0061954120
- 0061971287
- 0061971288
- 0061971325
- 0061973771
- 0061961001
- 0061967090
- 0061961847
- 0061972579
- 0061951279
- 0061954147
- 0061958274
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- B Braun Medical IncBethlehem, Pennsylvania
- Products made with it
- Medline Convenience Kits
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98838
- Recall numbers
- Z-2276-2026 to Z-2278-2026
All recalls from B Braun Medical Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
