FDA recall, Jun 13, 2026, High risk

Arrow International Vascular Access and Catheterization Kits

Paracentesis kits contain lidocaine, bupivacaine.

Summary by Recall Canary from the FDA notice

ARROW INTERNATIONAL, LLC of Morrisville, North Carolina is recalling kits and sets that contain lidocaine, bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

The recall began on April 21, 2026, and was classified by the FDA on June 12, 2026, with distribution nationwide including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

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.

A UDI-DI is the device identifier printed with the barcode on the device label.

Description/REF
1. UDI-DI
  10801902197136
  10801902193275
  10801902168525
  10801902222463
  10801902159950
  40801902111768
  30801902111785
  10801902213416
  10801902213409
  10801902213430
  0801902193275
  10801902213423
  10801902116793
  70801902123205
  10801902167795
  10801902221923
  10801902144956
  10801902222487
  10801902202281
  20801902123484
  10801902213621
  50801902123515
  10801902213539
  10801902213522
  10801902213492
  10801902213485
  50801902123584
  10801902213553
  10801902213546
  60801902123611
  10801902213515
  10801902213577
  10801902213560
  10801902213591
  10801902213614
  Lot code
  AK-15122-F
  33F24E0348
  33F24J0280
  33F24K0119
  33F24L0601
  33F25A0477
  33F25C0908
  33F24A0850
2. UDI-DI
  10801902193275
  10801902214925
  10801902201505
  10801902188288
  Lot code
  ASK-41552-LTAC
  33F24J0142
  33F24H0002
3. UDI-DI
  10801902210217
  10801902209938
  10801902209501
  10801902209518
  10801902209525
  10801902209532
  10801902209549
  10801902209556
  30801902121722
  10801902209570
  10801902193275
  10801902209617
  10801902209631
  10801902202199
  10801902209662
  10801902209716
  10801902209723
  10801902209730
  10801902209754
  10801902209983
  10801902210002
  10801902211221
  10801902202144
  10801902202090
  10801902210224
  10801902210262
  10801902140644
  10801902210330
  10801902202496
  10801902210354
  30801902202155
  10801902210361
  10801902210378
  10801902209747
  10801902210392
  10801902214857
  10801902209853
  10801902209860
  10801902209952
  10801902209969
  10801902211405
  10801902209976
  10801902210057
  10801902214840
  10801902202250
  10801902223651
  10801902209761
  10801902209785
  10801902209884
  10801902214918
  Lot code
  ASK-05502-VM1
  33F25C0168
  33F25C0880
  33F25E0202
  33F25G0134
  33F25H0126
  33F26C0297
  33F24C0216
4. UDI-DI
  30801902118807
  10801902193275
  20801902121756
  10801902117417
  20801902121916
  10801902119350
  10801902115222
  10801902118193
  10801902118209
  10801902119930
  10801902119947
  10801902119954
  10801902224344
  10801902189841
  10801902212006
  10801902196412
  60801902123093
  60801902116736
  40801902111768
  10801902189865
  10801902182545
  10801902119978
  30801902122248
  30801902122255
  10801902129953
  10801902118407
  10801902220827
  10801902112962
  50801902116821
  30801902116834
  10801902196511
  30801902122262
  10801902114065
  10801902136487
  10801902129502
  10801902119435
  10801902118902
  20801902117506
  10801902117516
  10801902117523
  10801902145847
  10801902118186
  10801902220810
  10801902220858
  10801902220735
  30801902117022
  10801902193114
  10801902200478
  10801902118216
  Lot code
  GU-04020
  33F24C0753
  33F24E0736
  33F24G0154
  33F24G0648
  33F24H0377
  33F25A0059
  33F25A0072
  33F25A0395
  33F25F0260
  33F25G0736
  33F25H0298
  33F25J0603
  33F26B0084
  33F26B0314
  33F26C0578
  33F24D0036
5. UDI-DI
  10801902193275
  Lot code
  CDC-32052-MPKC
  33F24L0236
6. UDI-DI
  10801902193275
  10801902167696
  10801902208702
  10801902208733
  10801902208825
  10801902208856
  10801902221077
  10801902208764
  10801902208771
  10801902188462
  10801902188479
  10801902221664
  10801902218886
  10801902208610
  10801902208634
  10801902186741
  60801902123420
  Lot code
  ASK-44063-NS
  33F25F0100
7. UDI-DI
  10801902193275
  10801902221909
  10801902196719
  60801902121709
  10801902121650
  10801902121674
  10801902192230
  10801902209501
  10801902168471
  10801902168488
  10801902168495
  10801902168518
  30801902122040
  10801902122077
  10801902197136
  10801902168532
  10801902168549
  10801902168563
  10801902168570
  30801902122248
  20801902114987
  10801902115260
  Lot code
  ASK-04510-MM6
  33F25E0590
  33F25G0196
  33F25M0005
  33F25M0149
  33F26A0302
  33F26C0723
  33F24K0212
8. UDI-DI
  10801902193275
  Lot code
  ASK-00376-JHH
  33F25G0629
  33F24K0592
9. UDI-DI
  10801902193275
  10801902218442
  10801902214338
  10801902133226
  10801902210217
  10801902214819
  30801902116919
  10801902191622
  30801902119514
  10801902202519
  1080190216099
  10801902160475
  10801902118421
  10801902205657
  10801902205695
  10801902220896
  0801902220896
  10801902216479
  10801902158717
  10801902136685
  10801902217131
  10801902220377
  10801902203189
  10801902141030
  10801902211672
  10801902221824
  10801902144734
  10801902142167
  10801902135244
  10801902225495
  10801902212020
  10801902219012
  10801902135022
  10801902159608
  10801902129465
  10801902159592
  10801902225150
  10801902208368
  10801902205206
  10801902159189
  30801902119576
  10801902205664
  10801902220384
  10801902164251
  10801902159585
  10801902225143
  10801902213829
  10801902202540
  40801902131469
  10801902219050
  10801902203257
  30801902119644
  1080190215812
  10801902202533
  10801902213782
  10801902135381
  10801902160970
  10801902160468
  10801902211467
  10801902205671
  10801902205749
  10801902220902
  10801902205213
  10801902216417
  10801902158724
  10801902217148
  10801902208344
  10801902220353
  10801902203158
  10801902211689
  10801902202861
  10801902221817
  10801902200508
  10801902201017
  10801902214833
  10801902142174
  10801902135237
  10801902205220
  10801902212082
  10801902143850
  10801902136654
  10801902159462
  10801902221053
  10801902125207
  10801902119749
  10801902219029
  10801902135046
  10801902159615
  10801902118674
  10801902113228
  10801902129489
  10801902156355
  10801902164268
  10801902144161
  10801902159554
  10801902225181
  10801902112948
  10801902213904
  10801902206944
  10801902208351
  10801902202366
  10801902203127
  10801902202557
  10801902205763
  10801902220360
  10801902224269
  10801902225471
  10801902159578
  10801902225167
  10801902214888
  10801902116700
  10801902162134
  10801902162141
  10801902162158
  10801902162165
  10801902167825
  10801902170863
  20801902117087
  10801902162080
  10801902162103
  10801902162097
  10801902170887
  10801902171525
  10801902168372
  10801902161243
  10801902162042
  10801902162110
  10801902168389
  10801902168396
  20801902118787
  20801902116400
  Lot code
  ASK-04001-JHH
  33F24K0748
  33F26A1669
  33F25G0558
10. UDI-DI
  10801902121551
  10801902193275
  10801902142983
  10801902138788
  10801902139839
  10801902193916
  10801902205909
  10801902195934
  10801902138801
  10801902202304
  10801902117639
  10801902117936
  30801902118012
  10801902139464
  10801902213386
  10801902139709
  10801902118087
  10801902140644
  10801902140583
  10801902140606
  10801902140637
  10801902140620
  10801902199734
  10801902199741
  10801902199758
  10801902140989
  10801902199765
  10801902145489
  10801902192063
  10801902218947
  10801902117660
  10801902144765
  20801902117711
  10801902117868
  10801902119916
  10801902221312
  10801902221329
  10801902130836
  10801902143805
  20801902114987
  10801902158854
  10801902117899
  Lot code
  AK-04020-SPC
  33F23M0171
  33F24C0729
  33F24E0699
  33F24G0596
  33F24H0057
  33F24J0350
  33F24J0458
  33F24K0615
  33F24M0126
  33F25A0338
  33F25B0039
  33F25B0131
  33F25D0192
  33F25D0281
  33F25E1109
  33F25F0496
  33F25J0764
  33F26B0054
11. Lot code
  ASK-04001-MC3
12. UDI-DI
  10801902193275
  10801902168471
  10801902186499
  10801902168532
  30801902111822
  10801902213430
  40801902111867
  10801902196498
  50801902123515
  Lot code
  AK-12123-PCDC
  33F24J0419
  33F25B0015
  33F25F0022
  33F25G0482
  33F25J0029
  33F25K0268
  33F26B0056
  33F24E0175
13. UDI-DI
  10801902193275
  Lot code
  ASK-04001-CG1
  33F25C0224
  33F25D0647
  33F25G0390
  33F25J0348
14. UDI-DI
  10801902225303
  10801902225273
  10801902225310
  Lot code
  SAC-01218-B
  33F26C0515
15. UDI-DI
  10801902193275
  10801902201994
  10801902202007
  10801902202014
  10801902202281
  10801902202274
  10801902210217
  10801902206692
  Lot code
  ASA-24090-SB
  33F24G0383
  33F24K0145
  33F24L0550
  33F25A0491
  33F25C0838
  33F25E0094
  33F25H0044
  33F25J0490
  33F25L0444
  33S25E0094
16. UDI-DI
  30801902123597
  10801902193275
  Lot code
  CDC-25142-X1A
  36F25E0021
  33F25B0467
17. UDI-DI
  10801902197129
  10801902193275
  10801902168464
  Lot code
  AK-12122-F
  33F24B0184
  33F24D0076
  33F24F0321
  33F24G0345
  33F24K0111
  33F25A0474
  33F25C0915
  33F25E0061
  33F25E0924
  33F25J0832
  33F25L0404
  33F26B0552
  33F24A0102
18. UDI-DI
  10801902193275
  50801902130162
  10801902218862
  10801902205411
  10801902205435
  10801902201505
  10801902205428
  10801902205442
  10801902201475
  10801902205398
  10801902205404
  10801902208757
  10801902216721
  10801902216462
  10801902216455
  10801902216677
  10801902208849
  10801902208856
  10801902208740
  10801902208863
  10801902216684
  10801902208665
  10801902216714
  10801902208672
  10801902216738
  10801902216745
  10801902216769
  50801902120699
  10801902217216
  10801902208603
  10801902222715
  10801902214895
  10801902156966
  10801902205688
  10801902159950
  10801902144956
  10801902168099
  10801902168105
  10801902135220
  10801902221916
  10801902222579
  10801902159486
  10801902163643
  10801902161007
  10801902200485
  10801902222586
  10801902134858
  10801902159745
  10801902220995
  10801902222784
  10801902160468
  10801902213850
  10801902144536
  10801902221947
  10801902222593
  10801902116373
  10801902221640
  10801902164268
  10801902162066
  10801902117202
  30801902117275
  Lot code
  CDC-02031-MK1A
  33F25C0444
19. UDI-DI
  30801902121722
  10801902193275
  20801902121756
  Lot code
  AK-09000
  33F24B0178
  33F24C0097
  33F24E0336
  33F24F0311
  33F24G0335
  33F24K0101
  33F24L0795
  33F25E0919
  33F25G0467
  33F25G0758
  33F25H0722
  33F25J0468
  33F25L0463
  33F26A0389
  33F24A0368
20. UDI-DI
  10801902193275
  10801902119268
  50801902117644
  10801902121384
  10801902117691
  10801902117769
  10801902117837
  10801902124927
  10801902117929
  10801902114041
  10801902118001
  10801902118025
  10801902118049
  10801902224177
  10801902119824
  10801902119855
  10801902128536
  10801902114089
  10801902117721
  10801902117776
  10801902117783
  30801902158896
  10801902117851
  30801902119927
  10801902162943
  10801902118070
  10801902117585
  Lot code
  NA-04220-1A
  33F26B0027
21. UDI-DI
  10801902210217
  Lot code
  ASK-07155-MGU
  33F25C0798
22. UDI-DI
  10801902193275
  10801902133110
  10801902212013
  10801902168464
  10801902186338
  10801902168525
  10801902186499
  10801902214338
  10801902164602
  10801902133226
  10801902116793
  10801902119978
  10801902119985
  10801902210217
  10801902167801
  20801902116974
  10801902168129
  60801902123611
  10801902168136
  50801902117019
  10801902167740
  10801902167764
  10801902118971
  60801902123178
  10801902167795
  10801902180381
  20801902117506
  10801902168044
  20801902116851
  10801902213591
  30801902116902
  30801902116919
  30801902122378
  30801902116896
  10801902202519
  10801902205657
  10801902223682
  10801902141030
  10801902137330
  10801902217155
  10801902205701
  10801902164251
  10801902159653
  10801902202540
  10801902223668
  10801902158120
  10801902223675
  10801902141047
  10801902130386
  10801902116229
  30801902116315
  10801902116335
  10801902116359
  10801902116373
  10801902119732
  10801902119749
  10801902114058
  10801902116465
  10801902116564
  30801902119774
  30801902119781
  10801902223699
  10801902143867
  10801902170870
  30801902117190
  10801902117202
  10801902224283
  10801902205664
  10801902171372
  10801902168167
  10801902119152
  10801902171389
  10801902168181
  10801902168198
  10801902225150
  10801902156966
  10801902225143
  10801902224313
  10801902225181
  10801902225167
  10801902224436
  10801902214888
  10801902168365
  10801902162103
  20801902117148
  10801902162134
  20801902117216
  10801902169720
  10801902162158
  10801902213751
  10801902156386
  10801902213768
  Lot code
  ASK-42802-PLH
  33F25L0140
  33F26B0222
  33F24F0799
23. UDI-DI
  10801902203172
  10801902193275
  10801902221084
  10801902216394
  10801902215014
  10801902217261
  Lot code
  ASK-09458-AH
  33F24C0359
  33F24C1122
  33F24E0323
  33F24F0780
  33F24K0397
  33F25A0208
  33F25B0518
  33F25D0001
  33F25D0338
  33F25D0465
  33F25E0528
  33F25H0610
  33F25J0353
  33F25K0076
  33F25K0091
  33F25M0173
  33F26A1538
  33F26B0819
  33F24H0227
24. UDI-DI
  10801902143874
  10801902193275
  10801902145847
  60801902116729
  10801902222500
  10801902222746
  10801902221022
  10801902222562
  10801902221633
  10801902211450
  10801902220698
  10801902141023
  10801902221930
  10801902193114
  10801902200478
  10801902135473
  Lot code
  ASK-09701-UP
  33F23K0811
  33F24B0340
  33F24E0524
  33F24G0489
  33F25C0874
  33F25E1018
  33F25H0747
  33F25J0795
  33F26A0402
  33F26B0243
  33F26B1031
25. UDI-DI
  10801902210217
  10801902193275
  10801902202106
  10801902209471
  10801902209433
  10801902206876
  10801902214291
  10801902210057
  10801902210064
  10801902202236
  40801902202220
  10801902202243
  10801902210125
  10801902210132
  10801902210149
  10801902209617
  10801902210385
  10801902214857
  10801902209853
  10801902202076
  10801902119916
  10801902202496
  10801902210354
  10801902210156
  Lot code
  ASK-04001-SUH-S
  33F25C0766
  33F25E0112
  33F25G0101
  33F25H0058
  33F25H0725
  33F25J0862
  33F25M0836
  33F25F0160
26. UDI-DI
  10801902121582
  10801902193275
  10801902121636
  20801902118787
  Lot code
  AK-04210
  33F24A1009
  33F24B0106
  33F24C0009
  33F24D0014
  33F24G0324
  33F24J0490
  33F24K0089
  33F24L0671
  33F25A0456
  33F25C0899
  33F25E0037
  33F25H0011
  33F25J0461
27. UDI-DI
  10801902193275
  30801902202155
  10801902192230
  10801902196719
  10801902117622
  10801902117639
  10801902211429
  10801902159776
  10801902138498
  30801902158896
  10801902200447
  10801902117943
  10801902139976
  10801902200461
  10801902118001
  10801902211412
  10801902115024
  10801902214796
  10801902115031
  10801902200454
  20801902214038
  10801902217018
  10801902118070
  30801902117367
  30801902117374
  10801902119930
  10801902190915
  10801902190939
  60801902121549
  10801902121551
  10801902190922
  20801902121572
  10801902121582
  10801902190946
  10801902121636
  10801902114898
  10801902193237
  10801902205916
  10801902117660
  30801902144578
  10801902206814
  10801902213379
  10801902193244
  10801902121384
  10801902225525
  20801902117711
  10801902213263
  10801902138757
  10801902117837
  10801902144550
  10801902145571
  60801902117849
  10801902143782
  10801902117851
  10801902159127
  10801902143805
  10801902139396
  10801902130836
  10801902221602
  10801902220834
  10801902119268
  10801902115048
  Lot code
  TJ-04020-1
  33F24J0338
  33F25A0158
  33F25C0753
  33F25E0281
  33F24B0409
28. UDI-DI
  10801902193275
  10801902139365
  10801902143874
  10801902212075
  1080190219327
  10801902161830
  10801902136678
  10801902212006
  20801902115205
  50801902116715
  60801902116729
  10801902196436
  10801902182545
  30801902122262
  80801902123127
  10801902218930
  10801902206685
  10801902200492
  10801902220728
  10801902159479
  10801902225365
  10801902129502
  10801902156348
  10801902196498
  10801902196504
  50801902116821
  10801902196511
  10801902196528
  20801902123484
  10801902214291
  10801902188899
  10801902129953
  10801902158878
  10801902134964
  10801902219135
  10801902220339
  10801902160987
  10801902118407
  10801902219036
  10801902159639
  10801902114065
  10801902220346
  10801902211443
  10801902225136
  10801902112986
  10801902221039
  10801902217087
  10801902144512
  10801902159622
  10801902159530
  10801902225174
  50801902117019
  60801902117030
  20801902117049
  10801902193190
  10801902193206
  10801902193121
  10801902160086
  10801902114881
  10801902189674
  10801902211986
  Lot code
  ASK-09701-UMH
  33F24M0171
  33F25A0444
  33F25G0008
  33F25K0039
  33F25L0133
  33F26B0369
  33F23K0811
29. UDI-DI
  50801902120156
  10801902193275
  60801902120160
  10801902190915
  10801902125726
  10801902205909
  10801902145120
  10801902194029
  10801902197952
  30801902120190
  10801902203134
  10801902114867
  10801902156232
  30801902120206
  Lot code
  AK-01600
  33F24A0376
  33F24A1008
  33F24C0091
  33F24D0067
  33F24E0321
  33F24G0322
  33F24L0062
  33F24L0811
  33F24M0267
  33F25C0101
  33F25C0988
  33F25E0035
  33F25H0010
  33F25J0819
  33F26B0492
  33F24A0044
30. UDI-DI
  10801902193275
  10801902140798
  10801902216677
  10801902208849
  10801902216660
  50801902120781
  10801902203271
  10801902170863
  10801902188332
  50801902116715
  Lot code
  DLX-35563-HPKC
  33F25D0520
31. UDI-DI
  10801902210217
  10801902211504
  10801902211481
  10801902197938
  10801902203172
  Lot code
  AI-06210-KS
  33F24G0127
  33F24H0302
  33F25E0321
  33F26A1322
  33F25B0008
32. UDI-DI
  10801902193275
  10801902197129
  50801902123195
  10801902136470
  10801902143690
  10801902136500
  10801902156379
  70801902123328
  10801902210071
  10801902213478
  10801902168044
  10801902213515
  10801902198492
  10801902222265
  10801902222319
  30801902123597
  Lot code
  AK-11802-F
  33F24G0344
  33F24J0511
  33F24L0637
  33F25A0473
  33F25E0060
  33F25J0473
  33F24A0848
33. UDI-DI
  10801902193275
  Lot code
  ASK-42703-PNHS2
  33F25J0107
34. UDI-DI
  10801902193275
  10801902208658
  10801902210118
  10801902219005
  10801902219067
  10801902201970
  10801902211887
  10801902158854
  Lot code
  DLX-45563-VPSB
  33F25C0704
  33F25D0316
  33F25D0627
  33F25M0094
  33F24L0860
Some entries omit identifying details. Check the notice to confirm which units are affected.
Paracentesis Kit, REF: AK-00376, ASK-00376-VCU
UDI-DI
10801902197938
10801902193275
10801902197952
10801902138788
Lot code
AK-00376
33F24D0004
33F24E0166
33F24G0318
33F24J0486
33F24K0083
33F24L0725
33F25A0453
33F25A0610
33F25C0749
33F25C0906
33F25E0031
33F25G0075
33F25H0007
33F25H0719
33F25J0739
33F25J0817
33F25L0462
33F25M0954
33F26B0949
33F26C0575
33F24A0016

Recall details

Company began the recall

Apr 21, 2026

Sold in

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

Company

ARROW INTERNATIONAL, LLCMorrisville, North Carolina

Hazard

Sterility problem

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

98793

Recall numbers

Z-2363-2026 to Z-2397-2026

All recalls from ARROW INTERNATIONAL, LLC

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

Apr 21, 2026
Company began the recall
Jun 12, 2026
Classified by FDA
Jun 13, 2026
Added to FDA's Enforcement Report
Jun 14, 2026
Listed on Recall Canary
Jun 24, 2026
In FDA's weekly enforcement report
Oct 3, 2026
Summary updated

What happened

What to do

Is your kit affected?

Description/REF

Paracentesis Kit, REF: AK-00376, ASK-00376-VCU

Recall details

Timeline

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