Z-1420-2026 Class II Ongoing

Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) MINOR EYE PACK, Model Number: DYNJ17219C; 12) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 13) EYE PACK, Model Number: DYNJ41207C; 14) OPHTHALMIC PACK, Model Number: DYNJ42043I; 15) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 16) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 17) EYE PLASTIC PACK, Model Number: DYNJ47859B; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) CATARACT PACK, Model Number: DYNJ53019A; 20) CATARACT PACK, Model Number: DYNJ54869A; 21) VITRECTOMY PACK, Model Number: DYNJ55280B; 22) NDNW-EYE PACK, Model Number: DYNJ61779C; 23) EYE PK, Model Number: DYNJ62306; 24) VITRECTOMY, Model Number: DYNJ64220; 25) OSC BREAST PACK, Model Number: DYNJ65808C; 26) MILLS CATARACT PACK, Model Number: DYNJ67973A; 27) EYE PACK, Model Number: DYNJ68367B; 28) CATARACT PACK, Model Number: DYNJ68875D; 29) CATARACT PACK, Model Number: DYNJ68875F; 30) CATARACT PACK, Model Number: DYNJ68875G; 31) OPHTHO PLASTIC, Model Number: DYNJ902256C; 32) RETINAL, Model Number: DYNJ907495; 33) CATARACT, Model Number: DYNJ909924; 34) COMBO EYE, Model Number: DYNJ909925; 35) VITRECTOMY, Model Number: DYNJ909929

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

1) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 22GBP895; 2) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21IBV636; 3) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21FBP706; 4) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21ABV400; 5) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 24EBU650; 6) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 23HBV380; 7) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22KBO773; 8) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS907; 9) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS899; 10) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22HBX475; 11) DYKMBNDL159, UDI-DI: 10193489478273(each), 40193489478274(case), Lot Number: 21ABQ655; 12) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21FBP773; 13) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21BBM375; 14) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21ABT655; 15) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21KLA277; 16) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ILA655; 17) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21HLA179; 18) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21FLA394; 19) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21BBK655; 20) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ABR620; 21) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23DBD264; 22) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23CBP086; 23) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24HBS367; 24) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24EBF870; 25) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24CBA180; 26) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24BBJ841; 27) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24ABH891; 28) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23LBI221; 29) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23KBJ008; 30) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23JBK353; 31) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23IBA614; 32) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23GBE628; 33) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23FBU438; 34) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23EBL613; 35) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23CBP088; 36) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21GBJ364; 37) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21DBC009; 38) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21ABT657; 39) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22OBC233; 40) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22GBW969; 41) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22FBB999; 42) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW535; 43) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW517; 44) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 21IBP918; 45) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25EBG033; 46) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBU487; 47) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBJ362; 48) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 24FBB728; 49) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBD243; 50) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBA356; 51) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBT177; 52) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBC619; 53) DYNJ17219C, UDI-DI: 10888277053007(each), 40888277053008(case), Lot Number: 21ADA445; 54) DYNJ38791M, UDI-DI: 10193489665437(each), 40193489665438(case), Lot Number: 23EBS726; 55) DYNJ41207C, UDI-DI: 10195327353063(each), 40195327353064(case), Lot Number: 23KMH083; 56) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21HMC573; 57) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21GMA744; 58) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21DMA925; 59) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21CMA770; 60) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21BMA716; 61) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 22BMD451; 62) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 22AMC045; 63) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21JMF395; 64) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21IMH317; 65) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21HMB926; 66) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21GMD097; 67) DYNJ45585C, UDI-DI: 10195327475512(each), 40195327475513(case), Lot Number: 23IBE143; 68) DYNJ47859B, UDI-DI: 10889942899739(each), 40889942899730(case), Lot Number: 21DBQ717; 69) DYNJ47859B, UDI-DI: 10889942899739(each), 40889942899730(case), Lot Number: 21CBJ926; 70) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25FBE320; 71) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25ABK875; 72) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24KBA576; 73) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24FBI469; 74) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24EBT972; 75) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24ABB652; 76) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23KBB813; 77) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23GBD486; 78) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23EBE835; 79) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23EBA347; 80) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23CBC335; 81) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22JBS972; 82) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22EBT342; 83) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22ABJ996; 84) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 21JBG678; 85) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 21FBM463; 86) DYNJ53019A, UDI-DI: 10889942582761(each), 40889942582762(case), Lot Number: 21ADA466; 87) DYNJ54869A, UDI-DI: 10889942606085(each), 40889942606086(case), Lot Number: 20XBF509; 88) DYNJ55280B, UDI-DI: 10193489919806(each), 40193489919807(case), Lot Number: 21GDB817; 89) DYNJ61779C, UDI-DI: 10195327379643(each), 40195327379644(case), Lot Number: 23EBQ641; 90) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22EBO615; 91) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22DBS613; 92) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22ABU477; 93) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21KBM947; 94) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21JBD854; 95) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21GBG219; 96) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21FBJ619; 97) DYNJ64220, UDI-DI: 10193489794618(each), 40193489794619(case), Lot Number: 21ABW916; 98) DYNJ65808C, UDI-DI: 10195327369064(each), 40195327369065(case), Lot Number: 23KMB340; 99) DYNJ67973A, UDI-DI: 10193489437386(each), 40193489437387(case), Lot Number: 22JBK486; 100) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23LMG710; 101) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23JMF562; 102) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23GMB569; 103) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23FMI783; 104) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23CMA209; 105) DYNJ68875D, UDI-DI: 10195327335076(each), 40195327335077(case), Lot Number: 23BBP426; 106) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23FBQ273; 107) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 23LBK778; 108) DYNJ902256C, UDI-DI: 10195327089368(each), 40195327089369(case), Lot Number: 22FDA445; 109) DYNJ907495, UDI-DI: 10193489462135(each), 40193489462136(case), Lot Number: 22KDB104; 110) DYNJ907495, UDI-DI: 10193489462135(each), 40193489462136(case), Lot Number: 21CDB771; 111) DYNJ909924, UDI-DI: 10195327506728(each), 40195327506729(case), Lot Number: 23LBJ479; 112) DYNJ909925, UDI-DI: 10195327506735(each), 40195327506736(case), Lot Number: 23LBJ480; 113) DYNJ909929, UDI-DI: 10195327506759(each), 40195327506750(case), Lot Number: 23LBJ481