Class 2 Device Recall Medline

• Date Initiated by Firm: December 16, 2025
• Date Posted: January 14, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1088-2026
• Recall Event ID: 98197
• Product Classification: Gynecological laparoscopic kit - Product Code OHD
• Product: Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G.
• Code Information: REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25FBF036; REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25DBB218; REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25DBP829; REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25CBI860; REF CDS980864Q: UDI/DI 10198459121937 (EA) 40198459121938 (CS), Lot number 25EMC533; REF CDS981583U: UDI/DI 10195327209766 (EA) 40195327209767 (CS), Lot number 25CBC570; REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25FBK816; REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25EBS462; REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25FBH633; REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25BBU420; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMI839; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMF861; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25CMC823; REF CDS982779N: UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25EBF365; REF CDS982779N: UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25CBM352; REF CDS982780V: UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25EBI642; REF CDS982780V: UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25DBP916; REF CDS982780V: UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25CBT429; REF CDS982857K: UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25FBR222; REF CDS982857K: UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25EBJ713; REF CDS982857K: UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25CBH758; REF CDS983393L: UDI/DI 10198459224614 (EA) 40198459224615 (CS), Lot number 25EBP657; REF CDS984656Q: UDI/DI 10198459107368 (EA) 40198459107369 (CS), Lot number 25CMG731; REF CDS984656Q: UDI/DI 10198459107368 (EA) 40198459107369 (CS), Lot number 25BME966; REF CDS984656R: UDI/DI 10198459312113 (EA) 40198459312114 (CS), Lot number 25DMI408; REF CDS984663J: UDI/DI 10198459019418 (EA) 40198459019419 (CS), Lot number 25CBM414; REF CDS985467J: UDI/DI 10195327689124 (EA) 40195327689125 (CS), Lot number 25BMF759; REF DYNJG901002B: UDI/DI 10195327677145 (EA) 40195327677146 (CS), Lot number 25FLA112; REF DYNJG901002B: UDI/DI 10195327677145 (EA) 40195327677146 (CS), Lot number 25ELA210; REF DYNJVB91075C: UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25ELA810; REF DYNJVB91075C: UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25ELA007; REF DYNJVB91075C: UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25DLA059; REF DYNJ36840L: UDI/DI 10198459331923 (EA) 40198459331924 (CS), Lot number 25EBB131; REF DYNJ38152D: UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25FLA334; REF DYNJ38152D: UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25DLA454; REF DYNJ38152D: UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25CLA543; REF DYNJ50649J: UDI/DI 10195327261504 (EA) 40195327261505 (CS), Lot number 25CBT190; REF DYNJ52096P: UDI/DI 10198459140778 (EA) 40198459140779 (CS), Lot number 25FDA204; REF DYNJ52096P: UDI/DI 10198459140778 (EA) 40198459140779 (CS), Lot number 25DDB877; REF DYNJ52564D: UDI/DI 10195327176426 (EA) 40195327176427 (CS), Lot number 25BMF583; REF DYNJ52564F: UDI/DI 10198459314162 (EA) 40198459314163 (CS), Lot number 25FMD560; REF DYNJ52564F: UDI/DI 10198459314162 (EA) 40198459314163 (CS), Lot number 25FMI642; REF DYNJ52581D: UDI/DI 10195327213886 (EA) 40195327213887 (CS), Lot number 25DMB242; REF DYNJ53782J: UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25EMI041; REF DYNJ53782J: UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25DMG684; REF DYNJ53782J: UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25CMD347; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25FMD297; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25DMH371; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25DMA836; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25CMH615; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25CMA935; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25FBD162; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBV003; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBO450; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBB005; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25FBS192; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25FBB252; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25DBU301; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25DBB429; REF DYNJ63392F: UDI/DI 10198459315572 (EA) 40198459315573 (CS), Lot number 25FLA272; REF DYNJ63392F: UDI/DI 10198459315572 (EA) 40198459315573 (CS), Lot number 25ELA626; REF DYNJ63392F: UDI/DI 10198459315572 (EA) 40198459315573 (CS), Lot number 25DLA944; REF DYNJ63456B: UDI/DI 10193489956504 (EA) 40193489956505 (CS), Lot number 25FBO125; REF DYNJ63456B: UDI/DI 10193489956504 (EA) 40193489956505 (CS), Lot number 25DBK731; REF DYNJ67177D: UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25FBD264; REF DYNJ67177D: UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25FBD519; REF DYNJ67177D: UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25EBE408; REF DYNJ67177D: UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25DBC173; REF DYNJ84433B: UDI/DI 10198459113598 (EA) 40198459113599 (CS), Lot number 25EBD020; REF DYNJ900963M: UDI/DI 10198459153426 (EA) 40198459153427 (CS), Lot number 25FBC396; REF DYNJ900963M: UDI/DI 10198459153426 (EA) 40198459153427 (CS), Lot number 25DBC417; REF DYNJ900963M: UDI/DI 10198459153426 (EA) 40198459153427 (CS), Lot number 25BBU398; REF DYNJ900965N: UDI/DI 10195327504991 (EA) 40195327504992 (CS), Lot number 25FBN962; REF DYNJ900965N: UDI/DI 10195327504991 (EA) 40195327504992 (CS), Lot number 25DBP344; REF DYNJ900965N: UDI/DI 10195327504991 (EA) 40195327504992 (CS), Lot number 25DBC207; REF DYNJ900967N: UDI/DI 10195327504984 (EA) 40195327504985 (CS), Lot number 25EBV490; REF DYNJ900967N: UDI/DI 10195327504984 (EA) 40195327504985 (CS), Lot number 25DBC354; REF DYNJ901018O: UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25FBJ418; REF DYNJ901018O: UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25EBK336; REF DYNJ901018O: UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25DBV042; REF DYNJ901018O: UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25CBL781; REF DYNJ901046M: UDI/DI 10198459130380 (EA) 40198459130381 (CS), Lot number 25FBM810; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMJ099; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMG577; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMD806; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMD755; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25DMB047; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25CMI669; REF DYNJ901796K: UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25EMI909; REF DYNJ901796K: UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25EME506; REF DYNJ901796K: UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25EMA622; REF DYNJ901796K: UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25CME376; REF DYNJ901844N: UDI/DI 10195327620981 (EA) 40195327620982 (CS), Lot number 25DBE209; REF DYNJ901845L: UDI/DI 10195327579197 (EA) 40195327579198 (CS), Lot number 25CBC628; REF DYNJ901845M: UDI/DI 10198459288159 (EA) 40198459288150 (CS), Lot number 25EBS830; REF DYNJ901850N: UDI/DI 10195327620998 (EA) 40195327620999 (CS), Lot number 25DBE377; REF DYNJ902029G: UDI/DI 10195327391256 (EA) 40195327391257 (CS), Lot number 25DBR019; REF DYNJ902029G: UDI/DI 10195327391256 (EA) 40195327391257 (CS), Lot number 25DBH434; REF DYNJ902029G: UDI/DI 10195327391256 (EA) 40195327391257 (CS), Lot number 25CBO260; REF DYNJ902513J: UDI/DI 10195327662745 (EA) 40195327662746 (CS), Lot number 25EBO161; REF DYNJ902540O: UDI/DI 10198459192265 (EA) 40198459192266 (CS), Lot number 25ELA305; REF DYNJ902540O: UDI/DI 10198459192265 (EA) 40198459192266 (CS), Lot number 25DLA166; REF DYNJ902540O: UDI/DI 10198459192265 (EA) 40198459192266 (CS), Lot number 25CLA999; REF DYNJ902583N: UDI/DI 10198459024764 (EA) 40198459024765 (CS), Lot number 25FBM125; REF DYNJ902583N: UDI/DI 10198459024764 (EA) 40198459024765 (CS), Lot number 25DBD973; REF DYNJ902583N: UDI/DI 10198459024764 (EA) 40198459024765 (CS), Lot number 25BBT778; REF DYNJ903459J: UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25FBB837; REF DYNJ903459J: UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25DBV160; REF DYNJ903459J: UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25CBK831; REF DYNJ903459J: UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25CBH604; REF DYNJ903647I: UDI/DI 10198459016820 (EA) 40198459016821 (CS), Lot number 25EBK700; REF DYNJ903827F: UDI/DI 10198459184901 (EA) 40198459184902 (CS), Lot number 25DMJ677; REF DYNJ903948R: UDI/DI 10198459104411 (EA) 40198459104412 (CS), Lot number 25CBL682; REF DYNJ903983P: UDI/DI 10198459231216 (EA) 40198459231217 (CS), Lot number 25FDB185; REF DYNJ903983P: UDI/DI 10198459231216 (EA) 40198459231217 (CS), Lot number 25DDA847; REF DYNJ903990Q: UDI/DI 10198459231261 (EA) 40198459231262 (CS), Lot number 25FDB213; REF DYNJ903990Q: UDI/DI 10198459231261 (EA) 40198459231262 (CS), Lot number 25BDB159; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25FBK097; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25EBN006; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25DBR174; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25DBB130; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25CBC542; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25FBJ386; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25EBG616; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25CBT550; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25CBO348; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25CBD568; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25EBT946; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25EBN312; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25EBM906; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25CBO254; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25CBH661; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25BBR098; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25BBJ047; REF DYNJ904597G: UDI/DI 10195327547493 (EA) 40195327547494 (CS), Lot number 25DMB367; REF DYNJ904597G: UDI/DI 10195327547493 (EA) 40195327547494 (CS), Lot number 25BMF447; REF DYNJ905289G: UDI/DI 10195327392987 (EA) 40195327392988 (CS), Lot number 25FBM315; REF DYNJ905289G: UDI/DI 10195327392987 (EA) 40195327392988 (CS), Lot number 25DBB336; REF DYNJ905289G: UDI/DI 10195327392987 (EA) 40195327392988 (CS), Lot number 25CBC157; REF DYNJ905730J: UDI/DI 10198459061462 (EA) 40198459061463 (CS), Lot number 25DMI347; REF DYNJ905730J: UDI/DI 10198459061462 (EA) 40198459061463 (CS), Lot number 25DME212; REF DYNJ905746J: UDI/DI 10198459061455 (EA) 40198459061456 (CS), Lot number 25DMI830; REF DYNJ905964G: UDI/DI 10198459156830 (EA) 40198459156831 (CS), Lot number 25FBQ752; REF DYNJ905964G: UDI/DI 10198459156830 (EA) 40198459156831 (CS), Lot number 25CBO349; REF DYNJ905985O: UDI/DI 10195327697693 (EA) 40195327697694 (CS), Lot number 25EDB456; REF DYNJ905985O: UDI/DI 10195327697693 (EA) 40195327697694 (CS), Lot number 25CDB971; REF DYNJ905985O: UDI/DI 10195327697693 (EA) 40195327697694 (CS), Lot number 25BDB112; REF DYNJ906051C: UDI/DI 10195327343392 (EA) 40195327343393 (CS), Lot number 25CBJ023; REF DYNJ906051D: UDI/DI 10198459287527 (EA) 40198459287528 (CS), Lot number 25DBH988; REF DYNJ906051D: UDI/DI 10198459287527 (EA) 40198459287528 (CS), Lot number 25DBE149; REF DYNJ906112B: UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25FBN075; REF DYNJ906112B: UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25EBT833; REF DYNJ906112B: UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25EBM894; REF DYNJ906112B: UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25DBG798; REF DYNJ906265D: UDI/DI 10195327456764 (EA) 40195327456765 (CS), Lot number 25DBB516; REF DYNJ906265D: UDI/DI 10195327456764 (EA) 40195327456765 (CS), Lot number 25CBK354; REF DYNJ906265F: UDI/DI 10198459339806 (EA) 40198459339807 (CS), Lot number 25FBI618; REF DYNJ906322F: UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25FBH720; REF DYNJ906322F: UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25EBF411; REF DYNJ906322F: UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25DBD977; REF DYNJ906322F: UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25DBB800; REF DYNJ906357C: UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25FBD902; REF DYNJ906357C: UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25EBN653; REF DYNJ906357C: UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25DBG849; REF DYNJ906357C: UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25CBE442; REF DYNJ906379D: UDI/DI 10198459131035 (EA) 40198459131036 (CS), Lot number 25FBK055; REF DYNJ906444C: UDI/DI 10195327362690 (EA) 40195327362691 (CS), Lot number 25EBL655; REF DYNJ906444C: UDI/DI 10195327362690 (EA) 40195327362691 (CS), Lot number 25DBA252; REF DYNJ906444C: UDI/DI 10195327362690 (EA) 40195327362691 (CS), Lot number 25CBJ638; REF DYNJ906543B: UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25EBP621; REF DYNJ906543B: UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25DBA268; REF DYNJ906543B: UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25CBN673; REF DYNJ906543B: UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25CBE740; REF DYNJ906731K: UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25FDA837; REF DYNJ906731K: UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25EDB457; REF DYNJ906731K: UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25CDA446; REF DYNJ906731K: UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25BDB494; REF DYNJ907072F: UDI/DI 10195327498481 (EA) 40195327498482 (CS), Lot number 25FLA043; REF DYNJ907153C: UDI/DI 10195327600778 (EA) 40195327600779 (CS), Lot number 25DBG686; REF DYNJ907153C: UDI/DI 10195327600778 (EA) 40195327600779 (CS), Lot number 25CBR320; REF DYNJ907153C: UDI/DI 10195327600778 (EA) 40195327600779 (CS), Lot number 25CBB606; REF DYNJ907153D: UDI/DI 10198459333606 (EA) 40198459333607 (CS), Lot number 25EBT961; REF DYNJ907153D: UDI/DI 10198459333606 (EA) 40198459333607 (CS), Lot number 25EBB608; REF DYNJ907492F: UDI/DI 10195327389789 (EA) 40195327389780 (CS), Lot number 25CMH362; REF DYNJ907492F: UDI/DI 10195327389789 (EA) 40195327389780 (CS), Lot number 25BMI302; REF DYNJ907599C: UDI/DI 10195327342593 (EA) 40195327342594 (CS), Lot number 25FBD904; REF DYNJ907599C: UDI/DI 10195327342593 (EA) 40195327342594 (CS), Lot number 25DBH124; REF DYNJ907635D: UDI/DI 10198459240690 (EA) 40198459240691 (CS), Lot number 25EBT433; REF DYNJ907635D: UDI/DI 10198459240690 (EA) 40198459240691 (CS), Lot number 25DBL490; REF DYNJ907635D: UDI/DI 10198459240690 (EA) 40198459240691 (CS), Lot number 25DBG765; REF DYNJ907647B: UDI/DI 10195327409142 (EA) 40195327409143 (CS), Lot number 25EBR238; REF DYNJ907647B: UDI/DI 10195327409142 (EA) 40195327409143 (CS), Lot number 25EBA853; REF DYNJ907647B: UDI/DI 10195327409142 (EA) 40195327409143 (CS), Lot number 25CBQ766; REF DYNJ907910F: UDI/DI 10198459253225 (EA) 40198459253226 (CS), Lot number 25FBL209; REF DYNJ907910F: UDI/DI 10198459253225 (EA) 40198459253226 (CS), Lot number 25FBE603; REF DYNJ907919C: UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25EMH024; REF DYNJ907919C: UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25CMG480; REF DYNJ907919C: UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25CMC385; REF DYNJ907919C: UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25CMB958; REF DYNJ908447D: UDI/DI 10195327610753 (EA) 40195327610754 (CS), Lot number 25CBA952; REF DYNJ908447F: UDI/DI 10198459301063 (EA) 40198459301064 (CS), Lot number 25FBM340; REF DYNJ908447F: UDI/DI 10198459301063 (EA) 40198459301064 (CS), Lot number 25EBE460; REF DYNJ908504A: UDI/DI 10195327251291 (EA) 40195327251292 (CS), Lot number 25CBP390; REF DYNJ908504A: UDI/DI 10195327251291 (EA) 40195327251292 (CS), Lot number 25CBK432; REF DYNJ908783F: UDI/DI 10198459100895 (EA) 40198459100896 (CS), Lot number 25DMC328; REF DYNJ908783F: UDI/DI 10198459100895 (EA) 40198459100896 (CS), Lot number 25CMG289; REF DYNJ909120D: UDI/DI 10198459130540 (EA) 40198459130541 (CS), Lot number 25DBJ949; REF DYNJ909547: UDI/DI 10195327395896 (EA) 40195327395897 (CS), Lot number 25CBP409; REF DYNJ909547: UDI/DI 10195327395896 (EA) 40195327395897 (CS), Lot number 25BBH373; REF DYNJ909548A: UDI/DI 10195327538309 (EA) 40195327538300 (CS), Lot number 25FBN965; REF DYNJ909548A: UDI/DI 10195327538309 (EA) 40195327538300 (CS), Lot number 25EBH875; REF DYNJ910137A: UDI/DI 10198459201561 (EA) 40198459201562 (CS), Lot number 25FBE605; REF DYNJ910137A: UDI/DI 10198459201561 (EA) 40198459201562 (CS), Lot number 25EBD597; REF DYNJ910137A: UDI/DI 10198459201561 (EA) 40198459201562 (CS), Lot number 25DBD951; REF DYNJ910991: UDI/DI 10198459242045 (EA) 40198459242046 (CS), Lot number 25EMH063; REF DYNJ910991: UDI/DI 10198459242045 (EA) 40198459242046 (CS), Lot number 25DMC222; REF DYNJ910995: UDI/DI 10198459242038 (EA) 40198459242039 (CS), Lot number 25CMH628; REF DYNJ9225761X: UDI/DI 10195327587475 (EA) 40195327587476 (CS), Lot number 25FMB646; REF DYNJ9225761X: UDI/DI 10195327587475 (EA) 40195327587476 (CS), Lot number 25DMA960; REF DYNJ9225761X: UDI/DI 10195327587475 (EA) 40195327587476 (CS), Lot number 25CMB504; REF DYNJ9288198X: UDI/DI 10198459133886 (EA) 40198459133887 (CS), Lot number 25EME557; REF DYNJ9288198X: UDI/DI 10198459133886 (EA) 40198459133887 (CS), Lot number 25DMG373; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25EMH286; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25DMH432; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25DMA405; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25BMI178; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25BME871; REF PHS722500G: UDI/DI 10198459009464 (EA) 40198459009465 (CS), Lot number 25EMD105; REF PHS722500G: UDI/DI 10198459009464 (EA) 40198459009465 (CS), Lot number 25CMH699; REF PHS722500G: UDI/DI 10198459009464 (EA) 40198459009465 (CS), Lot number 25BMI579.
• 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: 12584 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.