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:

Recall Summary Medline is recalling 35 different surgical and ophthalmic (eye surgery) convenience kits because equipment used to sterilize and package them may not have been properly calibrated. While all products went through sterilization processes, the calibration problems could have affected whether the products met required sterility standards. This is a Class II recall affecting medical facilities that use these kits.

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:...

Reason

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/93d077cd-13e5-4f00-a68c-282da0966628