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) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 12) MINOR EYE PACK, Model Number: DYNJ17219C; 13) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 14) EYE PACK, Model Number: DYNJ41207C; 15) OPHTHALMIC PACK, Model Number: DYNJ42043I; 16) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 17) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 18) EYE PLASTIC PACK, Model Number: DYNJ47859B; 19) EYE PLASTIC PACK, Model Number: DYNJ47859C; 20) CATARACT PACK, Model Number: DYNJ53019A; 21) CATARACT PACK, Model Number: DYNJ54869A; 22) VITRECTOMY PACK, Model Number: DYNJ55280B; 23) NDNW-EYE PACK, Model Number: DYNJ61779C; 24) EYE PK, Model Number: DYNJ62306; 25) VITRECTOMY, Model Number: DYNJ64220; 26) OSC BREAST PACK, Model Number: DYNJ65808C; 27) MILLS CATARACT PACK, Model Number: DYNJ67973A; 28) EYE PACK, Model Number: DYNJ68367B; 29) CATARACT PACK, Model Number: DYNJ68875D; 30) CATARACT PACK, Model Number: DYNJ68875F; 31) CATARACT PACK, Model Number: DYNJ68875G; 32) VITRECTOMY IP, Model Number: DYNJ84020; 33) PLASTIC PACK, Model Number: DYNJ86288; 34) OPHTHO PLASTIC, Model Number: DYNJ902256C; 35) RETINAL, Model Number: DYNJ907495; 36) CATARACT, Model Number: DYNJ909924; 37) CATARACT, Model Number: DYNJ909924A; 38) COMBO EYE, Model Number: DYNJ909925; 39) VITRECTOMY, Model Number: DYNJ909929; 40) RETINAL PK-LF, Model Number: DYNJC2364O
Enforcement
- Recall Number
- Z-2113-2026
- Event ID
- 98642
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 13, 2026
- Initiation Date
- January 7, 2026
- Classification Date
- May 7, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
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) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 12) MINOR EYE PACK, Model Number: DYNJ17219C; 13) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 14) EYE PACK, Model Number: DYNJ41207C; 15) OPHTHALMIC PACK, Model Number: DYNJ42043I; 16) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 17) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 18) EYE PLASTIC PACK, Model Number: DYNJ47859B; 19) EYE PLASTIC PACK, Model Number: DYNJ47859C; 20) CATARACT PACK, Model Number: DYNJ53019A; 21) CATARACT PACK, Model Number: DYNJ54869A; 22) VITRECTOMY PACK, Model Number: DYNJ55280B; 23) NDNW-EYE PACK, Model Number: DYNJ61779C; 24) EYE PK, Model Number: DYNJ62306; 25) VITRECTOMY, Model Number: DYNJ64220; 26) OSC BREAST PACK, Model Number: DYNJ65808C; 27) MILLS CATARACT PACK, Model Number: DYNJ67973A; 28) EYE PACK, Model Number: DYNJ68367B; 29) CATARACT PACK, Model Number: DYNJ68875D; 30) CATARACT PACK, Model Number: DYNJ68875F; 31) CATARACT PACK, Model Number: DYNJ68875G; 32) VITRECTOMY IP, Model Number: DYNJ84020; 33) PLASTIC PACK, Model Number: DYNJ86288; 34) OPHTHO PLASTIC, Model Number: DYNJ902256C; 35) RETINAL, Model Number: DYNJ907495; 36) CATARACT, Model Number: DYNJ909924; 37) CATARACT, Model Number: DYNJ909924A; 38) COMBO EYE, Model Number: DYNJ909925; 39) VITRECTOMY, Model Number: DYNJ909929; 40) RETINAL PK-LF, Model Number: DYNJC2364O
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: 21ABV400; 2) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21FBP706; 3) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21IBV636; 4) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 22GBP895; 5) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22HBX475; 6) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS899; 7) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS907; 8) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22KBO773; 9) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 23HBV380; 10) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 24EBU650; 11) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 25HBK503; 12) DYKMBNDL159, UDI-DI: 10193489478273(each), 40193489478274(case), Lot Number: 21ABQ655; 13) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21ABT655; 14) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21BBM375; 15) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21FBP773; 16) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ABR620; 17) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21BBK655; 18) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21FLA394; 19) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21HLA179; 20) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ILA655; 21) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21KLA277; 22) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23CBP086; 23) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23DBD264; 24) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23CBP088; 25) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23EBL613; 26) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23FBU438; 27) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23GBE628; 28) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23IBA614; 29) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23JBK353; 30) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23KBJ008; 31) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23LBI221; 32) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24ABH891; 33) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24BBJ841; 34) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24CBA180; 35) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24EBF870; 36) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24HBS367; 37) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21ABT657; 38) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21DBC009; 39) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21GBJ364; 40) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 21IBP918; 41) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW517; 42) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW535; 43) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22FBB999; 44) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22GBW969; 45) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22OBC233; 46) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBC619; 47) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBT177; 48) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBA356; 49) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBD243; 50) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 24FBB728; 51) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBJ362; 52) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBU487; 53) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25EBG033; 54) DYNJ17004L, UDI-DI: 10193489244144(each), 40193489244145(case), Lot Number: 23JBA703; 55) DYNJ17219C, UDI-DI: 10888277053007(each), 40888277053008(case), Lot Number: 21ADA445; 56) DYNJ38791M, UDI-DI: 10193489665437(each), 40193489665438(case), Lot Number: 23EBS726; 57) DYNJ41207C, UDI-DI: 10195327353063(each), 40195327353064(case), Lot Number: 23KMH083; 58) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21BMA716; 59) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21CMA770; 60) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21DMA925; 61) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21GMA744; 62) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21HMC573; 63) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21GMD097; 64) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21HMB926; 65) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21IMH317; 66) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21JMF395; 67) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 22AMC045; 68) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 22BMD451; 69) DYNJ45585C, UDI-DI: 10195327475512(each), 40195327475513(case), Lot Number: 23IBE143; 70) DYNJ47859B, UDI-DI: 10889942899739(each), 40889942899730(case), Lot Number: 21CBJ926; 71) DYNJ47859B, UDI-DI: 10889942899739(each), 40889942899730(case), Lot Number: 21DBQ717; 72) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 21FBM463; 73) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 21JBG678; 74) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22ABJ996; 75) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22EBT342; 76) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22JBS972; 77) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23CBC335; 78) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23EBA347; 79) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23EBE835; 80) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23GBD486; 81) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23KBB813; 82) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24ABB652; 83) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24EBT972; 84) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24FBI469; 85) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24KBA576; 86) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25ABK875; 87) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25BBT529; 88) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25FBE320; 89) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25GBQ388; 90) DYNJ53019A, UDI-DI: 10889942582761(each), 40889942582762(case), Lot Number: 21ADA466; 91) DYNJ54869A, UDI-DI: 10889942606085(each), 40889942606086(case), Lot Number: 20XBF509; 92) DYNJ55280B, UDI-DI: 10193489919806(each), 40193489919807(case), Lot Number: 21GDB817; 93) DYNJ61779C, UDI-DI: 10195327379643(each), 40195327379644(case), Lot Number: 23EBQ641; 94) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21FBJ619; 95) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21GBG219; 96) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21JBD854; 97) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21KBM947; 98) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22ABU477; 99) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22DBS613; 100) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22EBO615; 101) DYNJ64220, UDI-DI: 10193489794618(each), 40193489794619(case), Lot Number: 21ABW916; 102) DYNJ65808C, UDI-DI: 10195327369064(each), 40195327369065(case), Lot Number: 23KMB340; 103) DYNJ67973A, UDI-DI: 10193489437386(each), 40193489437387(case), Lot Number: 22JBK486; 104) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23CMA209; 105) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23FMI783; 106) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23GMB569; 107) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23JMF562; 108) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23LMG710; 109) DYNJ68875D, UDI-DI: 10195327335076(each), 40195327335077(case), Lot Number: 23BBP426; 110) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23FBQ273; 111) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23GBS486; 112) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23HBP752; 113) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23IBO012; 114) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 23LBK778; 115) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24BBG704; 116) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24CBN385; 117) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24FBR482; 118) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24IBM141; 119) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24JBT066; 120) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 24KBA594; 121) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 25ABO204; 122) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 25DBC415; 123) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 25DBS882; 124) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 25GBB923; 125) DYNJ84020, UDI-DI: 10195327327002(each), 40195327327003(case), Lot Number: 23GBU083; 126) DYNJ86288, UDI-DI: 10195327615468(each), 40195327615469(case), Lot Number: 24DBL612; 127) DYNJ86288, UDI-DI: 10195327615468(each), 40195327615469(case), Lot Number: 24EBM019; 128) DYNJ902256C, UDI-DI: 10195327089368(each), 40195327089369(case), Lot Number: 22FDA445; 129) DYNJ907495, UDI-DI: 10193489462135(each), 40193489462136(case), Lot Number: 21CDB771; 130) DYNJ907495, UDI-DI: 10193489462135(each), 40193489462136(case), Lot Number: 22KDB104; 131) DYNJ909924, UDI-DI: 10195327506728(each), 40195327506729(case), Lot Number: 23LBJ479; 132) DYNJ909924A, UDI-DI: 10198459182754(each), 40198459182755(case), Lot Number: 24KBT165; 133) DYNJ909925, UDI-DI: 10195327506735(each), 40195327506736(case), Lot Number: 23LBJ480; 134) DYNJ909925, UDI-DI: 10195327506735(each), 40195327506736(case), Lot Number: 24KBH632; 135) DYNJ909929, UDI-DI: 10195327506759(each), 40195327506750(case), Lot Number: 23LBJ481; 136) DYNJ909929, UDI-DI: 10195327506759(each), 40195327506750(case), Lot Number: 24KBM022; 137) DYNJC2364O, UDI-DI: 10193489908091(each), 40193489908092(case), Lot Number: 23JBJ429
Worldwide - US Nationwide distribution.
7760 units