Medline Convenience Kits: 1) Admit Kit, Model Number: Dyka1343a
Recall Summary Medline is recalling Convenience Kits (Admit Kit, Model DYKA1343A) because calibration problems with sterilization equipment may have affected whether the products are properly sterilized. Although all products went through sterilization and packaging processes, the calibration issues raise concerns about the sterility of the recalled items. This recall affects all units of this product.
- Product
- Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
- 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 I
- 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/b1c54962-6536-44fe-8c7d-5f336bcefb82