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RecallWatchMedical Device Safety
Class IIOngoingZ-1087-2026

Medline Industries, LP recalls Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS

Medline Industries, LPNorthfield, IL, United StatesReported Jan 21, 2026 · 5 months ago
Legal News Analyst ·

Reason for recall

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHOLE PACK, REF DYNJ57640F; 7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D; 8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D; 9) LAPAROSCOPY PACK, REF DYNJ68187B; 10) LAPAROSCOPY PACK, REF DYNJ82368A; 11) ROBOTIC KIDNEY PACK, REF DYNJ85261; 12) DOWNTOWN ROBOTICS, REF DYNJ86178B; 13) DAVINCI LITHOTOMY PACK, REF DYNJ87610; 14) ROBOTIC WHIPPLE PACK, REF DYNJ88433; 15) PROSTATE DAVINCI, REF DYNJ900127G; 16) GENERAL LAPAROSCOPY, REF DYNJ901847M; 17) LAG TLH, REF DYNJ901890N; 18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S; 19) LAP, REF DYNJ904576B; 20) ROBOTIC, REF DYNJ905147B; 21) ROBOTICS GYN, REF DYNJ905824M; 22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B; 23) CHN OR BASIC ROBOTIC, REF DYNJ905982I; 24) KIT ROBOTIC RFD, REF DYNJ906311F; 25) ROBOTIC PROSTATE, REF DYNJ906381G; 26) DAVINCI, REF DYNJ907392C; 27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C; 28) GYN, REF DYNJ908504B; 29) UROLOGY ROBOTIC, REF DYNJ908588I; 30) THORACIC ROBOTICS, REF DYNJ908777A; 31) GENERAL ROBOT, REF DYNJ908969A; 32) KIT ROBOTIC, REF DYNJ909870B; 33) ROBOTIC THORACOSCOPY, REF DYNJ910924.

Lot / code information

REF
CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS)
Lot #
25FBK870
REF
CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS)
Lot #
25EBD110
REF
CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS)
Lot #
25EBC253
REF
CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS)
Lot #
25DBG393
REF
CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS)
Lot #
25FBQ303
Show 136 more code fields
REF
CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS)
Lot #
25EBD631
REF
CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS)
Lot #
25DBM322
REF
CDS984640I: UDI/DI 10198459318955 (EA) 40198459318956 (CS)
Lot #
25DBT807
REF
DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS)
Lot #
25DMG099
REF
DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS)
Lot #
25CMJ006
REF
DYNJ57640F: UDI/DI 10198459011115 (EA) 40198459011116 (CS)
Lot #
25FDB347
REF
DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS)
Lot #
25EBK539
REF
DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS)
Lot #
25DBD145
REF
DYNJ63392D: UDI/DI 10198459164507 (EA) 40198459164508 (CS)
Lot #
25BLA967
REF
DYNJ68187B: UDI/DI 10198459382086 (EA) 40198459382087 (CS)
Lot #
25FMG440
REF
DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS)
Lot #
25EMH020
REF
DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS)
Lot #
25CMF917
REF
DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS)
Lot #
25FBK331
REF
DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS)
Lot #
25EBR783
REF
DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS)
Lot #
25EBP320
REF
DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS)
Lot #
25EBC981
REF
DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS)
Lot #
25DBA834
REF
DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS)
Lot #
25CBM884
REF
DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS)
Lot #
25FBK123
REF
DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS)
Lot #
25EBF929
REF
DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS)
Lot #
25CBT135
REF
DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS)
Lot #
25FMC215
REF
DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS)
Lot #
25EMF199
REF
DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS)
Lot #
25EMC621
REF
DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS)
Lot #
25FBO994
REF
DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS)
Lot #
25EBE439
REF
DYNJ901847M: UDI/DI 10198459037863 (EA) 40198459037864 (CS)
Lot #
25BBM364
REF
DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS)
Lot #
25FBJ408
REF
DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS)
Lot #
25EBJ877
REF
DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS)
Lot #
25EBO236
REF
DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS)
Lot #
25EBC133
REF
DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS)
Lot #
25DMH506
REF
DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS)
Lot #
25DMD329
REF
DYNJ905147B: UDI/DI 10193489569032 (EA) 40193489569033 (CS)
Lot #
25GDB060
REF
DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS)
Lot #
25DMK337
REF
DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS)
Lot #
25CMF465
REF
DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS)
Lot #
25EBG945
REF
DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS)
Lot #
25CBM218
REF
DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS)
Lot #
25EMD118
REF
DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS)
Lot #
25DMJ823
REF
DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS)
Lot #
25CMJ265
REF
DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS)
Lot #
25CMC374
REF
DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS)
Lot #
25CMC546
REF
DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS)
Lot #
25EBI860
REF
DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS)
Lot #
25DBR934
REF
DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS)
Lot #
25CBF096
REF
DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS)
Lot #
25FBJ655
REF
DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS)
Lot #
25FBE873
REF
DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS)
Lot #
25EBB258
REF
DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS)
Lot #
25DBR935
REF
DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS)
Lot #
25DMH137
REF
DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS)
Lot #
25CMJ730
REF
DYNJ907405C: UDI/DI 10195327541392 (EA) 40195327541393 (CS)
Lot #
25CMF429
REF
DYNJ908504B: UDI/DI 10198459318221 (EA) 40198459318222 (CS)
Lot #
25FBG752
REF
DYNJ908504B: UDI/DI 10198459318221 (EA) 40198459318222 (CS)
Lot #
25DBS537
REF
DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS)
Lot #
25FDA930
REF
DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS)
Lot #
25EDB953
REF
DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS)
Lot #
25EDA576
REF
DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS)
Lot #
25DDA437
REF
DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS)
Lot #
25CDB060
REF
DYNJ908777A: UDI/DI 10195327415174 (EA) 40195327415175 (CS)
Lot #
25CBA577
REF
DYNJ908777A: UDI/DI 10195327415174 (EA) 40195327415175 (CS)
Lot #
25CBA577Z
REF
DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS)
Lot #
25EBI127
REF
DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS)
Lot #
25CBP413
REF
DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS)
Lot #
25CBD522
REF
DYNJ909870B: UDI/DI 10198459122446 (EA) 40198459122447 (CS)
Lot #
25EBF813
REF
DYNJ909870B: UDI/DI 10198459122446 (EA) 40198459122447 (CS)
Lot #
25DBD407
REF
DYNJ910924: UDI/DI 10198459203442 (EA) 40198459203443 (CS)
Lot #
25EBK656

What the firm is doing

Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/16/2025 via email and USPS first class mail. The notice explained the issue, potential risk, and requested the following: "1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2.Please use the link and the information below to complete your response form. Please list the quantityof affected product you have in inventory on the form. Even if you do not have any affected productin inventory, please complete and submit the form. Website link: https://recalls.medline.comRecall Reference #: R-25-145-FGX5 Recall Code: 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4.If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com."

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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