Eye Tray
Recall Summary Medline is recalling two Convenience Kits (Eye Pack and Heart Cath Pack) that contain 10mL colored syringes because the syringes were changed in ways that were not approved by the FDA. The affected kits were distributed across the United States, Canada, Panama, and Barbados. This is a Class II recall, meaning the products could cause serious health problems or fail to work as intended.
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
- Reason
- Unapproved design changes to the products outside of the 510(k) clearance.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-27
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c011654b-e4d4-4094-849c-a21e3bd7590d