Recall archive / FDA device enforcement
Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3)... — FDA record Z-1088-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 16, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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; ...
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 12584 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1088-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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:... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 21, 2026
- Recall initiation date
- Dec 16, 2025
- Center classification date
- Jan 14, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.