FDA Medical devices recall · May 13, 2026

Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE… recall

Read the official FDA notice ↗

Product

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

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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), 4

Distribution

Worldwide - US Nationwide distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2113-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.