CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
Medline Convenience Kits: Kit Ophthalmic Rupture Globe recalled
Medline Industries is recalling Medline Convenience Kits: Kit Ophthalmic Rupture Globe, distributed nationwide in the US. The recall was initiated on 7 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2113-2026
- FDA event ID
- 98642
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jan 2026
- FDA classified
- 7 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 7 Jan 2026 | Recall initiated by company | |
| 7 May 2026 | Classified by FDA | +120 days |
| 13 May 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
35 other products · FDA event 98642This product is part of a recall event; the main page for the event is See RES for complete list recalled by Medline Industries.
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