FDA recall, , Moderate risk
Medline Medical Procedure Convenience Kits
Medline medical procedure convenience kits can leak and emit vaporized saline that resembles smoke during use.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP, of Northfield, Illinois, recalled medical procedure convenience kits containing Stryker's Strykeflow 2 Suction Irrigators because a 2024 design change allows irrigation solution to travel to the handpiece and battery pack during use, causing some devices to leak and/or emit vaporized saline that can resemble smoke.
The FDA added the recall to its Enforcement Report on January 14, 2026, after Medline began the recall on December 16, 2025. The kits were distributed nationwide in the United States.
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?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medline medical procedure convenience kits
- UDI-DI
- 10198459121814
- 40198459121815
- 10195327306793
- 40195327306794
- 10195327312565
- 40195327312566
- 10198459043086
- 40198459043087
- 10195327464929
- 40195327464920
- 10195327699154
- 40195327699155
- 10198459231384
- 40198459231385
- 10195327391249
- 40195327391240
- 10195327393014
- 40195327393015
- 10198459202025
- 40198459202026
- 10198459131042
- 40198459131043
- 10198459050398
- 40198459050399
- 10198459204326
- 40198459204327
- Lot code
- 25EMD795
- 25EBR237
- 25EBP591
- 25DBM353
- 25CBL184
- 25BBL633
- 25FBK918
- 25CBJ496
- 25FBF371
- 25EBK493
- 25DBH895
- 25DBC272
- 25CBU642
- 25CBJ298
- 25BBU206
- 25FBA261
- 25CBN230
- 25FDB398
- 25DDA191
- 25BDB095
- 25DBJ371
- 25BBS130
- 25FBJ689
- 25EBP700
- 25DBG283
- 25FBJ430
- 25FBC561
- 25EBK650
- 25EBE453
- 25CBS527
- 25FMC511
- 25CMJ281
- UDI-DI
- 10198459232626
- 40198459232627
- 10198459008245
- 40198459008246
- 10198459148101
- 40198459148102
- 10198459318955
- 40198459318956
- 10198459236907
- 40198459236908
- 10198459011115
- 40198459011116
- 10198459049767
- 40198459049768
- 10198459164507
- 40198459164508
- 10198459382086
- 40198459382087
- 10198459258077
- 40198459258078
- 10195327483418
- 40195327483419
- 10198459104800
- 40198459104801
- 10198459047817
- 40198459047818
- 10198459157936
- 40198459157937
- 10193489851588
- 40193489851589
- 10198459037863
- 40198459037864
- 10198459300592
- 40198459300593
- 10198459332883
- 40198459332884
- 10888277776760
- 40888277776761
- 10193489569032
- 40193489569033
- 10198459303272
- 40198459303273
- 10195327592707
- 40195327592708
- 10195327251420
- 40195327251421
- 10198459080494
- 40198459080495
- 10198459131066
- 40198459131067
- 10195327541378
- 40195327541379
- 10195327541392
- 40195327541393
- 10198459318221
- 40198459318222
- 10198459231544
- 40198459231545
- 10195327415174
- 40195327415175
- 10198459003950
- 40198459003951
- 10198459122446
- 40198459122447
- 10198459203442
- 40198459203443
- Lot code
- 25FBK870
- 25EBD110
- 25EBC253
- 25DBG393
- 25FBQ303
- 25EBD631
- 25DBM322
- 25DBT807
- 25DMG099
- 25CMJ006
- 25FDB347
- 25EBK539
- 25DBD145
- 25BLA967
- 25FMG440
- 25EMH020
- 25CMF917
- 25FBK331
- 25EBR783
- 25EBP320
- 25EBC981
- 25DBA834
- 25CBM884
- 25FBK123
- 25EBF929
- 25CBT135
- 25FMC215
- 25EMF199
- 25EMC621
- 25FBO994
- 25EBE439
- 25BBM364
- 25FBJ408
- 25EBJ877
- 25EBO236
- 25EBC133
- 25DMH506
- 25DMD329
- 25GDB060
- 25DMK337
- 25CMF465
- 25EBG945
- 25CBM218
- 25EMD118
- 25DMJ823
- 25CMJ265
- 25CMC374
- 25CMC546
- 25EBI860
- 25DBR934
- 25CBF096
- 25FBJ655
- 25FBE873
- 25EBB258
- 25DBR935
- 25DMH137
- 25CMJ730
- 25CMF429
- 25FBG752
- 25DBS537
- 25FDA930
- 25EDB953
- 25EDA576
- 25DDA437
- 25CDB060
- 25CBA577
- 25CBA577Z
- 25EBI127
- 25CBP413
- 25CBD522
- 25EBF813
- 25DBD407
- 25EBK656
- UDI-DI
- 10198459269196
- 40198459269197
- 10198459326318
- 40198459326319
- Lot code
- 25EBD732
- 25FBA103
- UDI-DI
- 10195327508913
- 40195327508914
- 10195327508920
- 40195327508921
- 10198459121937
- 40198459121938
- 10195327209766
- 40195327209767
- 10198459311390
- 40198459311391
- 10198459224805
- 40198459224806
- 10198459229039
- 40198459229030
- 10195327647711
- 40195327647712
- 10195327647728
- 40195327647729
- 10193489927863
- 40193489927864
- 10198459224614
- 40198459224615
- 10198459107368
- 40198459107369
- 10198459312113
- 40198459312114
- 10198459019418
- 40198459019419
- 10195327689124
- 40195327689125
- 10195327677145
- 40195327677146
- 10195327543693
- 40195327543694
- 10198459331923
- 40198459331924
- 10195327500993
- 40195327500994
- 10195327261504
- 40195327261505
- 10198459140778
- 40198459140779
- 10195327176426
- 40195327176427
- 10198459314162
- 40198459314163
- 10195327213886
- 40195327213887
- 10195327545093
- 40195327545094
- 10195327532758
- 40195327532759
- 10198459303753
- 40198459303754
- 10198459206672
- 40198459206673
- 10198459315572
- 40198459315573
- 10193489956504
- 40193489956505
- 10195327669768
- 40195327669769
- 10198459113598
- 40198459113599
- 10198459153426
- 40198459153427
- 10195327504991
- 40195327504992
- 10195327504984
- 40195327504985
- 10195327474881
- 40195327474882
- 10198459130380
- 40198459130381
- 10198459258008
- 40198459258009
- 10193489979701
- 40193489979702
- 10195327620981
- 40195327620982
- 10195327579197
- 40195327579198
- 10198459288159
- 40198459288150
- 10195327620998
- 40195327620999
- 10195327391256
- 40195327391257
- 10195327662745
- 40195327662746
- 10198459192265
- 40198459192266
- 10198459024764
- 40198459024765
- 10198459258473
- 40198459258474
- 10198459016820
- 40198459016821
- 10198459184901
- 40198459184902
- 10198459104411
- 40198459104412
- 10198459231216
- 40198459231217
- 10198459231261
- 40198459231262
- 10198459125584
- 40198459125585
- 10198459079054
- 40198459079055
- 10198459254802
- 40198459254803
- 10195327547493
- 40195327547494
- 10195327392987
- 40195327392988
- 10198459061462
- 40198459061463
- 10198459061455
- 40198459061456
- 10198459156830
- 40198459156831
- 10195327697693
- 40195327697694
- 10195327343392
- 40195327343393
- 10198459287527
- 40198459287528
- 10195327597375
- 40195327597376
- 10195327456764
- 40195327456765
- 10198459339806
- 40198459339807
- 10198459080562
- 40198459080563
- 10193489867985
- 40193489867986
- 10198459131035
- 40198459131036
- 10195327362690
- 40195327362691
- 10198459026164
- 40198459026165
- 10195327436346
- 40195327436347
- 10195327498481
- 40195327498482
- 10195327600778
- 40195327600779
- 10198459333606
- 40198459333607
- 10195327389789
- 40195327389780
- 10195327342593
- 40195327342594
- 10198459240690
- 40198459240691
- 10195327409142
- 40195327409143
- 10198459253225
- 40198459253226
- 10195327270193
- 40195327270194
- 10195327610753
- 40195327610754
- 10198459301063
- 40198459301064
- 10195327251291
- 40195327251292
- 10198459100895
- 40198459100896
- 10198459130540
- 40198459130541
- 10195327395896
- 40195327395897
- 10195327538309
- 40195327538300
- 10198459201561
- 40198459201562
- 10198459242045
- 40198459242046
- 10198459242038
- 40198459242039
- 10195327587475
- 40195327587476
- 10198459133886
- 40198459133887
- 10195327587659
- 40195327587650
- 10198459009464
- 40198459009465
- Lot code
- 25FBF036
- 25DBB218
- 25DBP829
- 25CBI860
- 25EMC533
- 25CBC570
- 25FBK816
- 25EBS462
- 25FBH633
- 25BBU420
- 25DMI839
- 25DMF861
- 25CMC823
- 25EBF365
- 25CBM352
- 25EBI642
- 25DBP916
- 25CBT429
- 25FBR222
- 25EBJ713
- 25CBH758
- 25EBP657
- 25CMG731
- 25BME966
- 25DMI408
- 25CBM414
- 25BMF759
- 25FLA112
- 25ELA210
- 25ELA810
- 25ELA007
- 25DLA059
- 25EBB131
- 25FLA334
- 25DLA454
- 25CLA543
- 25CBT190
- 25FDA204
- 25DDB877
- 25BMF583
- 25FMD560
- 25FMI642
- 25DMB242
- 25EMI041
- 25DMG684
- 25CMD347
- 25FMD297
- 25DMH371
- 25DMA836
- 25CMH615
- 25CMA935
- 25FBD162
- 25DBV003
- 25DBO450
- 25DBB005
- 25FBS192
- 25FBB252
- 25DBU301
- 25DBB429
- 25FLA272
- 25ELA626
- 25DLA944
- 25FBO125
- 25DBK731
- 25FBD264
- 25FBD519
- 25EBE408
- 25DBC173
- 25EBD020
- 25FBC396
- 25DBC417
- 25BBU398
- 25FBN962
- 25DBP344
- 25DBC207
- 25EBV490
- 25DBC354
- 25FBJ418
- 25EBK336
- 25DBV042
- 25CBL781
- 25FBM810
- 25EMJ099
- 25EMG577
- 25EMD806
- 25EMD755
- 25DMB047
- 25CMI669
- 25EMI909
- 25EME506
- 25EMA622
- 25CME376
- 25DBE209
- 25CBC628
- 25EBS830
- 25DBE377
- 25DBR019
- 25DBH434
- 25CBO260
- 25EBO161
- 25ELA305
- 25DLA166
- 25CLA999
- 25FBM125
- 25DBD973
- 25BBT778
- 25FBB837
- 25DBV160
- 25CBK831
- 25CBH604
- 25EBK700
- 25DMJ677
- 25CBL682
- 25FDB185
- 25DDA847
- 25FDB213
- 25BDB159
- 25FBK097
- 25EBN006
- 25DBR174
- 25DBB130
- 25CBC542
- 25FBJ386
- 25EBG616
- 25CBT550
- 25CBO348
- 25CBD568
- 25EBT946
- 25EBN312
- 25EBM906
- 25CBO254
- 25CBH661
- 25BBR098
- 25BBJ047
- 25DMB367
- 25BMF447
- 25FBM315
- 25DBB336
- 25CBC157
- 25DMI347
- 25DME212
- 25DMI830
- 25FBQ752
- 25CBO349
- 25EDB456
- 25CDB971
- 25BDB112
- 25CBJ023
- 25DBH988
- 25DBE149
- 25FBN075
- 25EBT833
- 25EBM894
- 25DBG798
- 25DBB516
- 25CBK354
- 25FBI618
- 25FBH720
- 25EBF411
- 25DBD977
- 25DBB800
- 25FBD902
- 25EBN653
- 25DBG849
- 25CBE442
- 25FBK055
- 25EBL655
- 25DBA252
- 25CBJ638
- 25EBP621
- 25DBA268
- 25CBN673
- 25CBE740
- 25FDA837
- 25EDB457
- 25CDA446
- 25BDB494
- 25FLA043
- 25DBG686
- 25CBR320
- 25CBB606
- 25EBT961
- 25EBB608
- 25CMH362
- 25BMI302
- 25FBD904
- 25DBH124
- 25EBT433
- 25DBL490
- 25DBG765
- 25EBR238
- 25EBA853
- 25CBQ766
- 25FBL209
- 25FBE603
- 25EMH024
- 25CMG480
- 25CMC385
- 25CMB958
- 25CBA952
- 25FBM340
- 25EBE460
- 25CBP390
- 25CBK432
- 25DMC328
- 25CMG289
- 25DBJ949
- 25CBP409
- 25BBH373
- 25FBN965
- 25EBH875
- 25FBE605
- 25EBD597
- 25DBD951
- 25EMH063
- 25DMC222
- 25CMH628
- 25FMB646
- 25DMA960
- 25CMB504
- 25EME557
- 25DMG373
- 25EMH286
- 25DMH432
- 25DMA405
- 25BMI178
- 25BME871
- 25EMD105
- 25CMH699
- 25BMI579
- UDI-DI
- 10198459258664
- 40198459258665
- 10198459282607
- 40198459282608
- 10195327572242
- 40195327572243
- 10195327641511
- 40195327641512
- 10195327255855
- 40195327255856
- 10195327191078
- 40195327191079
- 10198459134333
- 40198459134334
- 10198459138959
- 40198459138950
- 10195327694210
- 40195327694211
- 10198459114564
- 40198459114565
- 10198459043154
- 40198459043155
- 10198459023774
- 40198459023775
- 10198459265167
- 40198459265168
- 10198459352614
- 40198459352615
- 10193489692150
- 40193489692151
- 10198459241611
- 40198459241612
- 10195327045210
- 40195327045211
- 10198459136382
- 40198459136383
- 10193489468106
- 40193489468107
- 10198459206641
- 40198459206642
- 10193489428070
- 40193489428071
- 10193489950540
- 40193489950541
- 10195327668884
- 40195327668885
- 10195327384494
- 40195327384495
- 10195327404932
- 40195327404933
- 10198459133947
- 40198459133948
- 10198459291524
- 40198459291525
- 10195327488741
- 40195327488742
- 10198459281716
- 40198459281717
- 10195327394608
- 40195327394609
- 10198459149016
- 40198459149017
- 10195327603960
- 40195327603961
- 10195327468675
- 40195327468676
- 10195327524456
- 40195327524457
- 10198459231377
- 40198459231378
- 10198459288142
- 40198459288143
- 10198459288166
- 40198459288167
- 10198459288173
- 40198459288174
- 10195327388485
- 40195327388486
- 10195327662608
- 40195327662609
- 10198459176401
- 40198459176402
- 10198459250194
- 40198459250195
- 10198459222733
- 40198459222734
- 10198459222740
- 40198459222741
- 10195327550622
- 40195327550623
- 10198459230530
- 40198459230531
- 10198459071881
- 40198459071882
- 10195327052386
- 40195327052387
- 10195327048112
- 40195327048113
- 10198459346309
- 40198459346300
- 10198459131677
- 40198459131678
- 10193489752021
- 40193489752022
- 10198459346293
- 40198459346294
- 10198459061493
- 40198459061494
- 10195327282066
- 40195327282067
- 10198459117435
- 40198459117436
- 10198459080579
- 40198459080570
- 10198459080456
- 40198459080457
- 10198459130496
- 40198459130497
- 10195327433734
- 40195327433735
- 10195327433598
- 40195327433599
- 10195327600860
- 40195327600861
- 10195327624156
- 40195327624157
- 10198459320507
- 40198459320508
- 10195327591182
- 40195327591183
- 10198459130526
- 40198459130527
- 10198459013751
- 40198459013752
- 10195327660628
- 40195327660629
- 10195327552657
- 40195327552658
- 10198459129544
- 40198459129545
- 10195327661854
- 40195327661855
- 10198459234316
- 40198459234317
- Lot code
- 25EMH913
- 25EMC376
- 25CMJ688
- 25CME476
- 25EBM987
- 25CBT666
- 25FBP815
- 25EBN002
- 25CBN212
- 25FBN760
- 25EBD329
- 25DBN040
- 25DBK313
- 25CBE452
- 25DMH793
- 25DMC405
- 25EBN676
- 25DBO816
- 25CBJ724
- 25BBK265
- 25EMG591
- 25DMH851
- 25CMH945
- 25EBS490
- 25EBI971
- 25DBO242
- 25CBO208
- 25BDA838
- 25BDA425
- 25CBP120
- 25BBN336
- 25FBG772
- 25EBG794
- 25DBF556
- 25CBQ563
- 25EDC051
- 25BMG526
- 25FMA594
- 25EBD946
- 25CBS951
- 25EBH485
- 25DBK606
- 25CBN430
- 25FBK260
- 25EBH397
- 25DBT090
- 25FDA326
- 25CDA693
- 25EMF946
- 25CMG793
- 25FBI408
- 25CBR811
- 25BBR383
- 25DBG032
- 25EBA558
- 25DBC195
- 25FBM369
- 25DBF833
- 25DBC575
- 25CBI966
- 25FMB779
- 25DMD529
- 25DMH940
- 25BMH074
- 25CMB055
- 25FMC540
- 25CMG686
- 25CMD691
- 25EBL562
- 25CBP974
- 25CMF548
- 25DBP346
- 25CBH795
- 25FBE871
- 25EBG615
- 25EBH921
- 25DBR923
- 25CBH718
- 25FDA155
- 25EDA571
- 25CDA197
- 25FBG897
- 25EBJ874
- 25DBM222
- 25FBH903
- 25EBH888
- 25EBV494
- 25DBD971
- 25EBQ971
- 25CBR575
- 25EBH883
- 25DBC358
- 25EMD967
- 25DMG347
- 25EMH930
- 25DMB723
- 25EME835
- 25DMJ465
- 25DMF401
- 25BMJ071
- 25FMD784
- 25FBC756
- 25EBF091
- 25HBJ124
- 25FBF713
- 25DBJ916
- 25DBM300
- 25EBO479
- 25DBF405
- 25DBG629
- 25EBN370
- 25CBR398
- 25FBS728
- 25EBI282
- 25CBK566
- 25EBK030
- 25DBF506
- 25FBN971
- 25DMI831
- 25FBL810
- 25EBN681
- 25CBT634
- 25FMA366
- 25EMB405
- 25DMJ507
- 25CMI539
- 25CMD374
- 25EBJ685
- 25CBN214
- 25EBP431
- 25DBG969
- 25CBD708
- 25CBR473
- 25EBO230
- 25DBN709
- 25CBF802
- 25FBJ387
- 25EBG494
- 25DBF817
- 25FBL808
- 25EBO292
- 25CBU472
- 25CBF619
- 25CLA613
- 25BLA456
- 25FLA028
- 25ELA953
- 25DLA736
- 25EBK350
- 25BBI977
- 25FBP681
- 25CBM187
- 25EBB901
- 25FBP547
- 25FBG101
- 25EBK620
- 25EMA608
- 25CMI012
- 25FBU030
- 25FBB531
- 25DBO255
- 25EMF578
- 25DMG348
- 25FBR251
- 25FBE132
Medline medical procedure convenience kits labeled as: Kit Robotics Urology Prostate, REF DYKMBNDL116G
- UDI-DI
- 10198459156991
- 40198459156992
- Lot code
- 25EBM426
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98197
- Recall numbers
- Z-1085-2026 to Z-1090-2026
All recalls from Medline Industries, LP
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
In FDA's weekly enforcement report
Listed on Recall Canary
