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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Procedure Kits Recalled for Strykeflow 2 Suction Irrigator Smoke Risk

Agency Publication Date: January 14, 2026
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Summary

Medline Industries, LP is recalling 60,117 medical procedure convenience kits that contain Stryker's Strykeflow 2 Suction Irrigators. A design change in 2024 allows irrigation solution to leak into the device's handpiece and battery pack during use. This defect can cause the device to leak fluid or emit vaporized saline, which may look like smoke and could lead to device failure or serious injury.

Risk

The irrigation solution entering the battery pack and handpiece can cause the device to short-circuit, potentially resulting in burns, electric shock, or the emission of vaporized saline. If the device fails during a surgery, it could cause surgical delays or harm to patients and medical staff.

What You Should Do

  1. This recall affects over 60,000 Medline medical procedure convenience kits including Thoracic Robotics, Laparoscopy, Robotic Urology, and General Surgical packs that contain the Stryker Strykeflow 2 Suction Irrigator.
  2. Identification of affected products can be made by checking the REF (catalog) number and kit lot number located on the product label. Due to the high number of affected kits, please see the Affected Products section below for the full list of REF and lot numbers.
  3. Stop using the recalled products immediately. Contact Medline Industries or your medical supply distributor to arrange for the return, replacement, or correction of the kits containing the affected suction irrigators.
  4. Healthcare providers should report any adverse events or quality problems experienced with the use of this product to Medline or directly to the FDA's MedWatch program.
  5. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline medical procedure convenience kits (Thoracic/Cardiac)
Variants: THORACIC ROBOTICS, CARDIAC ROBOTIC WHC KIT-LF
Model / REF:
DYNJ908777B
DYNJ911359
Lot Numbers:
25EBD732
25FBA103
UDI:
10198459269196
40198459269197
10198459326318
40198459326319

Recall Z-1085-2026

Product: Medline medical procedure convenience kits (Laparoscopy/General)
Variants: LAPAROSCOPY CDS-LF, GENERAL LAPAROSCOPIC, LAP CHOLE CDS, LAPAROSCOPY PELV CDS, LAP CHOLE CDS-LF, LAP CHOLE KIT, LAP CHOLE-LF, LAP COLON CDS, GENERAL LAPAROSCOPY CDS, LAP CHOLE, GENERAL LAPAROSCOPY V, LAP CHOLE PACK, GENERAL LAPAROSCOPY PACK, DR. BROWN LAP CHOLE PLUS SETUP, LAPAROSCOPY GENERAL PACK, LAPAROSCOPY PACK, ENDOSCOPY, LAPAROSCOPIC CHOLECYSTECTO, LAP OB PACK, LAP CHOLE PACK-LF, LEX GENERAL LAPAROSCOPY, BARIATRIC KIT, GENERAL LAPAROSCOPY SOMC-LF, LAP GASTRIC SLEEVE, GENERAL LAP GASTRIC, GENERAL LAPAROSCOPY, LOU LAP SIGMOID COLON, LEX BARIATRIC, BARIATRIC, LAP APPY, GENERAL SURGERY LAPAROSCOPY, KIT GENERAL LAPAROSCOPY MHS, KIT GENERAL LAPAROSCOPY WEILER, KIT GENERAL LAP WAKEFIELD, LAP BARIATRIC, KIT LAPAROSCOPIC GASTRIC B, LAP CHOLE RFD, KIT LAP COLON RFD, GASTRIC SLEEVE, PROSTATECTOMY LAP ROBOTIC, LAP ROBOTIC SURG ONCOLOGY, GEN BARIATRIC, LAPAROSCOPIC, ROBOTIC GASTRIC LAP SLEEVE-LF, LAPAROSCOPIC GASTRIC ADD ON, BARIATRIC CENTRASTATE, LAP GENERAL THEDA, LAPAROSCOPIC CHOLE PACK, ROBOTIC THORACIC
Model / REF (72):
CDS860235L
CDS930223M
CDS983678K
CDS983679K
CDS983752M
CDS984016B
CDS984020P
CDS984175J
CDS984849N
CDS985328M
DYNJQ9044O
DYNJS2032F
DYNJ26209R
DYNJ26209S
DYNJ37459D
DYNJ42578G
DYNJ45083G
DYNJ51785D
DYNJ61652A
DYNJ62133A
DYNJ66285A
DYNJ66289B
DYNJ67296D
DYNJ68187A
DYNJ68741A
DYNJ81408A
DYNJ81408B
DYNJ85318
DYNJ89677
DYNJ900969J
DYNJ901126G
DYNJ901145I
DYNJ901164M
DYNJ901504L
DYNJ901827X
DYNJ901847N
DYNJ901848L
DYNJ901870J
DYNJ902033L
DYNJ902515K
DYNJ902565K
DYNJ902995I
DYNJ903163L
DYNJ903164L
DYNJ903733C
DYNJ904693D
DYNJ904891N
DYNJ905071F
DYNJ905390F
DYNJ905390G
Lot Numbers (165):
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
UDI (144):
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

Recall Z-1086-2026

Product: Medline medical procedure convenience kits (Robotic/Thoracic)
Variants: WCH BARI-GASTRECTOMY CDS, ROBOTIC PROCEDURE, CUH THORACIC, THORACIC PROCEDURE, DAVINCI ROBOTIC PACK-LF, LAP CHOLE PACK, GYN/PROSTATE ROBOTIC PACK, RR-DAVINCI PROSTATE ACCESSORY, LAPAROSCOPY PACK, ROBOTIC KIDNEY PACK, DOWNTOWN ROBOTICS, DAVINCI LITHOTOMY PACK, ROBOTIC WHIPPLE PACK, PROSTATE DAVINCI, LAG TLH, LITHOTOMY ROBOTIC CDS, ROBOTIC, ROBOTICS GYN, WH DAVINCI TLH PROCEDURE, CHN OR BASIC ROBOTIC, KIT ROBOTIC RFD, ROBOTIC PROSTATE, DAVINCI, CHIASSON GASTRIC SLEEVE KIT, UROLOGY ROBOTIC, GENERAL ROBOT, KIT ROBOTIC, ROBOTIC THORACOSCOPY
Model / REF:
CDS860237AF
CDS982128Q
CDS984338M
CDS984640I
DYNJ0525321O
DYNJ57640F
DYNJ62594D
DYNJ63392D
DYNJ68187B
DYNJ82368A
DYNJ85261
DYNJ86178B
DYNJ87610
DYNJ88433
DYNJ900127G
DYNJ901847M
DYNJ901890N
DYNJ903948S
DYNJ904576B
DYNJ905147B
DYNJ905824M
DYNJ905920B
DYNJ905982I
DYNJ906311F
DYNJ906381G
DYNJ907392C
DYNJ907405C
DYNJ908504B
DYNJ908588I
DYNJ908777A
DYNJ908969A
DYNJ909870B
DYNJ910924
Lot Numbers (73):
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
UDI (66):
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

Recall Z-1087-2026

Product: Medline medical procedure convenience kits (Robotic GYN/Urology)
Variants: ROBOTIC, ROBOTIC GYN, DAVINCI PROCEDURE, GYN-URO LAPSCP CDS-LF, GYN ROBOTIC, DEPAUL DAVINCI CDS, GU DAVINCI, GYN DAVINCI, UNIVERSAL ROBOTIC ORLANDO, ROBOTIC GU/GYN, GYN LAPAROSCOPY CDS, DAVINCI CDS UCC-LF, ROBOTIC UROLOGY PROSTATE, DAVINCI PROSTATECTOMY, ROBOTIC PACK, ROBOTIC PACK MNMC, WMC GYN LAPAROSCOPY PACK-LF, ROBOTIC GASTRIC BYPASS PACK, SCRIPPS SW ROBOTIC PACK, GYN ROBOTIC PACK, GYN LAPAROSCOPY PACK, UNIVERSAL DAVINCI ROBOTIC P, WALKER GYN-UROLOGY ROBOTIC PK, TOTAL LAPAROSCOPIC HYST PACK, MH GYN LAPAROSCOPY PACK-LF, LEX DAVINCI GYN MAJOR, LEX DAVINCI UROLOGY, COR DAVINCI, LOU GENERAL ROBOT, LOU GYN LAPAROSCOPY, LOU LITHOTOMY ROBOTIC, LEX GYN MINOR LAPAROSCOPY, GYN ROBOT, CHN OR DAVINCI PROSTATE, WMC ROBOTIC PACK - LF, ROBOTIC GYN & GU, GYN LAPAROSCOPY-LF, ROBOTIC UROLOGY, LITHOTOMY ROBOTIC CDS, GYN LAP, ROBOTIC-LF, ROBOT GYN, ROBOTIC PROSTECTOMY, URO ROBOTIC, COLON KIT, CHN OR ROBOTIC GYN, CW ROBOT, ROBOT, CDS ROBOTIC GYN CH, ROBOTIC GYN PACK, KIT GYN LAPAROSCOPY RFD, ROBOTIC COLON, GYN DAVINCI FOAKS, CHN GYN ONCOLOGY, CHN ROBOTIC CYSTECTOMY, WMC THORACIC ROBOTIC, KIT LAP GYN NTX, KIT ROBOTIC GYN, ROBOTIC GENERAL, ROBOTIC BASE, GYN, GU DAVINCI KIT, OSC ROBOT BARIATRIC, LEX DAVINCI PROSTATE, GYN-URO ROBOT, PROSTATECTOMY ROBOTIC, MB GYN ROBOTIC ADD, PHS722500FCK
Model / REF (96):
CDS980523M
CDS980647K
CDS980864Q
CDS981583U
CDS981583V
CDS981826K
CDS982377K
CDS982779N
CDS982780V
CDS982857K
CDS983393L
CDS984656Q
CDS984656R
CDS984663J
CDS985467J
DYNJG901002B
DYNJVB91075C
DYNJ36840L
DYNJ38152D
DYNJ50649J
DYNJ52096P
DYNJ52564D
DYNJ52564F
DYNJ52581D
DYNJ53782J
DYNJ53968P
DYNJ57458B
DYNJ62136B
DYNJ63392F
DYNJ63456B
DYNJ67177D
DYNJ84433B
DYNJ900963M
DYNJ900965N
DYNJ900967N
DYNJ901018O
DYNJ901046M
DYNJ901076L
DYNJ901796K
DYNJ901844N
DYNJ901845L
DYNJ901845M
DYNJ901850N
DYNJ902029G
DYNJ902513J
DYNJ902540O
DYNJ902583N
DYNJ903459J
DYNJ903647I
DYNJ903827F
Lot Numbers (230):
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
UDI (192):
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

Recall Z-1088-2026

Product: Medline medical procedure convenience kits (LAVH/Hysterectomy)
Variants: LAVH PROCEDURE, GYN LAP HYSTERECTOMY CDS, DAVINCI HYSTERECTOMY CDS, LAVH, LAPAROSCOPIC HYSTERECTOMY, ROBOTIC LAVH, LAVH-LF, LEX LAP HYST, LITHOTOMY-SLINGS-LF, GYN LAPAROSCOPY, ROBOTIC HYSTERECTOMY, LAVH GYN/ONC
Model / REF:
CDS980754T
CDS982662Q
CDS985344F
DYNJQ9041R
DYNJ900244I
DYNJ901281I
DYNJ901829T
DYNJ902030J
DYNJ905274D
DYNJ905485J
DYNJ906380C
DYNJ910634
DYNJ910927
Lot Numbers:
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:
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

Recall Z-1089-2026

Product: Medline medical procedure convenience kits (Urology/Prostate)
Variants: KIT ROBOTICS UROLOGY PROSTATE
Model / REF:
DYKMBNDL116G
Lot Numbers:
25EBM426
UDI:
10198459156991
40198459156992

Recall Z-1090-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98197
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Authorized Medical Distributors; Direct from Medline Industries
Manufactured In: United States
Units Affected: 6 products (96 units; 41432 units; 4536 units; 12584 units; 1457 units; 12 units)
Distributed To: Nationwide

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.