Class 2 Device Recall Medline

• Date Initiated by Firm: December 16, 2025
• Date Posted: January 14, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1086-2026
• Recall Event ID: 98197
• Product Classification: laparoscopy kit - Product Code FDE
• Product: Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF, REF CDS984016B; 7) LAP CHOLE KIT, REF CDS984020P; 8) LAP CHOLE-LF, REF CDS984175J; 9) LAP COLON CDS, REF CDS984849N; 10) GENERAL LAPAROSCOPY CDS, REF CDS985328M; 11) LAP CHOLE, REF DYNJQ9044O; 12) GENERAL LAPAROSCOPY V, REF DYNJS2032F; 13) LAP CHOLE PACK, REF DYNJ26209R; 14) LAP CHOLE PACK, REF DYNJ26209S; 15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D; 16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G; 17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G; 18) LAP CHOLE PACK, REF DYNJ51785D; 19) LAPAROSCOPY PACK, REF DYNJ61652A; 20) ENDOSCOPY, REF DYNJ62133A; 21) LAP CHOLE PACK, REF DYNJ66285A; 22) LAPAROSCOPY PACK, REF DYNJ66289B; 23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D; 24) LAPAROSCOPY PACK, REF DYNJ68187A; 25) LAP OB PACK, REF DYNJ68741A; 26) LAP CHOLE PACK-LF, REF DYNJ81408A; 27) LAP CHOLE PACK-LF, REF DYNJ81408B; 28) LAP CHOLE PACK, REF DYNJ85318; 29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677; 30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J; 31) LAP CHOLE, REF DYNJ901126G; 32) BARIATRIC KIT, REF DYNJ901145I; 33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M; 34) LAP GASTRIC SLEEVE, REF DYNJ901504L; 35) GENERAL LAP GASTRIC, REF DYNJ901827X; 36) GENERAL LAPAROSCOPY, REF DYNJ901847N; 37) LOU LAP SIGMOID COLON, REF DYNJ901848L; 38) LAP CHOLE, REF DYNJ901870J; 39) LEX BARIATRIC, REF DYNJ902033L; 40) BARIATRIC, REF DYNJ902515K; 41) LAP CHOLE CDS, REF DYNJ902565K; 42) LAP CHOLE, REF DYNJ902995I; 43) LAP CHOLE, REF DYNJ903163L; 44) LAP APPY, REF DYNJ903164L; 45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C; 46) LAP CHOLE, REF DYNJ904693D; 47) BARIATRIC, REF DYNJ904891N; 48) LAPAROSCOPY, REF DYNJ905071F; 49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F; 50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G; 51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D; 52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A; 53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B; 54) LAP BARIATRIC, REF DYNJ905733K; 55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A; 56) LAP CHOLE, REF DYNJ906277D; 57) LAP CHOLE RFD, REF DYNJ906302D; 58) KIT LAP COLON RFD, REF DYNJ906315D; 59) GASTRIC SLEEVE, REF DYNJ906355D; 60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C; 61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C; 62) GEN BARIATRIC, REF DYNJ907639D; 63) LAP CHOLE, REF DYNJ908415B; 64) LAP CHOLE, REF DYNJ908415C; 65) LAPAROSCOPIC, REF DYNJ908569B; 66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G; 67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A; 68) BARIATRIC CENTRASTATE, REF DYNJ909817A; 69) LAP GENERAL THEDA, REF DYNJ910050; 70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A; 71) ROBOTIC THORACIC, REF DYNJ910386; 72) BARIATRIC, REF DYNJ911017.
• Code Information: REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMH913; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMC376; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CMJ688; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CME476; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25EBM987; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25CBT666; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25FBP815; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25EBN002; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25CBN212; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25FBN760; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25EBD329; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBN040; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBK313; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25CBE452; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMH793; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMC405; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25EBN676; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25DBO816; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25CBJ724; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25BBK265; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25EMG591; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25DMH851; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25CMH945; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBS490; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBI971; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25DBO242; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25CBO208; REF CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA838; REF CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA425; REF CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25CBP120; REF CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25BBN336; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25FBG772; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25EBG794; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25DBF556; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25CBQ563; REF DYNJS2032F: UDI/DI 10198459023774 (EA)40198459023775 (CS), Kit Lot Number 25EDC051; REF DYNJ26209R: UDI/DI 10198459265167 (EA)40198459265168 (CS), Kit Lot Number 25BMG526; REF DYNJ26209S: UDI/DI 10198459352614 (EA)40198459352615 (CS), Kit Lot Number 25FMA594; REF DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25EBD946; REF DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25CBS951; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25EBH485; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25DBK606; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25CBN430; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25FBK260; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25EBH397; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25DBT090; REF DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25FDA326; REF DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25CDA693; REF DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25EMF946; REF DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25CMG793; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25FBI408; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25CBR811; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25BBR383; REF DYNJ66285A: UDI/DI 10193489428070 (EA)40193489428071 (CS), Kit Lot Number 25DBG032; REF DYNJ66289B: UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25EBA558; REF DYNJ66289B: UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25DBC195; REF DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25FBM369; REF DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25DBF833; REF DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25DBC575; REF DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25CBI966; REF DYNJ68187A: UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25FMB779; REF DYNJ68187A: UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25DMD529; REF DYNJ68741A: UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25DMH940; REF DYNJ68741A: UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25BMH074; REF DYNJ81408A: UDI/DI 10198459133947 (EA)40198459133948 (CS), Kit Lot Number 25CMB055; REF DYNJ81408B: UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25FMC540; REF DYNJ81408B: UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMG686; REF DYNJ81408B: UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMD691; REF DYNJ85318: UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25EBL562; REF DYNJ85318: UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25CBP974; REF DYNJ89677: UDI/DI 10198459281716 (EA)40198459281717 (CS), Kit Lot Number 25CMF548; REF DYNJ900969J: UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25DBP346; REF DYNJ900969J: UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25CBH795; REF DYNJ901126G: UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25FBE871; REF DYNJ901126G: UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25EBG615; REF DYNJ901145I: UDI/DI 10195327603960 (EA)40195327603961 (CS), Kit Lot Number 25EBH921; REF DYNJ901164M: UDI/DI 10195327468675 (EA)40195327468676 (CS), Kit Lot Number 25DBR923; REF DYNJ901504L: UDI/DI 10195327524456 (EA)40195327524457 (CS), Kit Lot Number 25CBH718; REF DYNJ901827X: UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25FDA155; REF DYNJ901827X: UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25EDA571; REF DYNJ901827X: UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25CDA197; REF DYNJ901847N: UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25FBG897; REF DYNJ901847N: UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25EBJ874; REF DYNJ901847N: UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25DBM222; REF DYNJ901848L: UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25FBH903; REF DYNJ901848L: UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25EBH888; REF DYNJ901870J: UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25EBV494; REF DYNJ901870J: UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25DBD971; REF DYNJ902033L: UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25EBQ971; REF DYNJ902033L: UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25CBR575; REF DYNJ902515K: UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25EBH883; REF DYNJ902515K: UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25DBC358; REF DYNJ902565K: UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25EMD967; REF DYNJ902565K: UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25DMG347; REF DYNJ902995I: UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25EMH930; REF DYNJ902995I: UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25DMB723; REF DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25EME835; REF DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMJ465; REF DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMF401; REF DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25BMJ071; REF DYNJ903164L: UDI/DI 10198459222740 (EA)40198459222741 (CS), Kit Lot Number 25FMD784; REF DYNJ903733C: UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25FBC756; REF DYNJ903733C: UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25EBF091; REF DYNJ904693D: UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25HBJ124; REF DYNJ904693D: UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25FBF713; REF DYNJ904693D: UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25DBJ916; REF DYNJ904891N: UDI/DI 10198459071881 (EA)40198459071882 (CS), Kit Lot Number 25DBM300; REF DYNJ905071F: UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25EBO479; REF DYNJ905071F: UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBF405; REF DYNJ905071F: UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBG629; REF DYNJ905390F: UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25EBN370; REF DYNJ905390F: UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25CBR398; REF DYNJ905390G: UDI/DI 10198459346309 (EA)40198459346300 (CS), Kit Lot Number 25FBS728; REF DYNJ905407D: UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25EBI282; REF DYNJ905407D: UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25CBK566; REF DYNJ905413A: UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25EBK030; REF DYNJ905413A: UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25DBF506; REF DYNJ905413B: UDI/DI 10198459346293 (EA)40198459346294 (CS), Kit Lot Number 25FBN971; REF DYNJ905733K: UDI/DI 10198459061493 (EA)40198459061494 (CS), Kit Lot Number 25DMI831; REF DYNJ905856A: UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25FBL810; REF DYNJ905856A: UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25EBN681; REF DYNJ905856A: UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25CBT634; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25FMA366; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25EMB405; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25DMJ507; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25CMI539; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25CMD374; REF DYNJ906302D: UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit Lot Number 25EBJ685; REF DYNJ906302D: UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit Lot Number 25CBN214; REF DYNJ906315D: UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25EBP431; REF DYNJ906315D: UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25DBG969; REF DYNJ906315D: UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25CBD708; REF DYNJ906355D: UDI/DI 10198459130496 (EA)40198459130497 (CS), Kit Lot Number 25CBR473; REF DYNJ906805C: UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25EBO230; REF DYNJ906805C: UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25DBN709; REF DYNJ906805C: UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25CBF802; REF DYNJ906824C: UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25FBJ387; REF DYNJ906824C: UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25EBG494; REF DYNJ906824C: UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25DBF817; REF DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25FBL808; REF DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25EBO292; REF DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25CBU472; REF DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25CBF619; REF DYNJ908415B: UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit Lot Number 25CLA613; REF DYNJ908415B: UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit Lot Number 25BLA456; REF DYNJ908415C: UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25FLA028; REF DYNJ908415C: UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25ELA953; REF DYNJ908415C: UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25DLA736; REF DYNJ908569B: UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit Lot Number 25EBK350; REF DYNJ908569B: UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit Lot Number 25BBI977; REF DYNJ909119G: UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit Lot Number 25FBP681; REF DYNJ909119G: UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit Lot Number 25CBM187; REF DYNJ909628A: UDI/DI 10198459013751 (EA)40198459013752 (CS), Kit Lot Number 25EBB901; REF DYNJ909817A: UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25FBP547; REF DYNJ909817A: UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25FBG101; REF DYNJ909817A: UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25EBK620; REF DYNJ910050: UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit Lot Number 25EMA608; REF DYNJ910050: UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit Lot Number 25CMI012; REF DYNJ910139A: UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25FBU030; REF DYNJ910139A: UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25FBB531; REF DYNJ910139A: UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25DBO255; REF DYNJ910386: UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit Lot Number 25EMF578; REF DYNJ910386: UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit Lot Number 25DMG348; REF DYNJ911017: UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit Lot Number 25FBR251; REF DYNJ911017: UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit Lot Number 25FBE132.
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 800-359-1704
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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."
• Quantity in Commerce: 41432 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.