Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE — Class II medical device recall Z-1420-2026
Ongoing recall by Medline Industries, LP, reported 2026-02-25, distributed nationwide. Medline has identified issues related to calibration of the equipment used to sterilize and package the device
| Recall number | Z-1420-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-01-07 |
| Classified | 2026-02-17 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Quantity | 4,853 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489389340, 10193489437386, 10193489462135, 10193489477931, 10193489478273, 10193489478464, 10193489478884, 10193489478945, 10193489641943, 10193489665437, 10193489794618, 10193489859812, 10193489916065, 10193489919806, 10193489975482, 10195327089368, 10195327240622, 10195327241223, 10195327276935, 10195327335076, 10195327353063, 10195327369026, 10195327369064, 10195327369200, 10195327379643 and 45 more |
| Lot numbers | 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 20XBF509, 21ABQ655, 21ABR620, 21ABT655, 21ABT657, 21ABV400, 21ABW916, 21ADA445, 21ADA466, 21BBK655, 21BBM375, 21BMA716, 21CBJ926, 21CDB771, 21CMA770, 21DBC009, 21DBQ717, 21DMA925, 21FBJ619, 21FBM463, 21FBP706, 21FBP773, 21FLA394, 21GBG219, 21GBJ364, 21GDB817 and 87 more |
| Model numbers | DYKMBNDL104, DYKMBNDL104A, DYKMBNDL159, DYKMBNDL180, DYKMBNDL42, DYKMBNDL43B, DYKMBNDL84B, DYKMBNDL98, DYKMBNDL98A, DYKMBNDL98B, DYNJ17219C, DYNJ38791M, DYNJ41207C, DYNJ42043I, DYNJ44852J, DYNJ45585C, DYNJ47859B, DYNJ47859C, DYNJ53019A, DYNJ54869A, DYNJ55280B, DYNJ61779C, DYNJ62306, DYNJ64220, DYNJ65808C and 10 more |
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) 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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1420-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.