Ear, Nose, And Throat Surgical Tray
Recall Summary Medline is recalling Convenience Kits containing colored 10mL syringes that are part of ear, nose, and throat surgical trays (specific product codes listed) because the syringes were modified in ways that weren't approved by the FDA. The affected products were distributed nationwide in the US and also sold in Canada, Panama, and Barbados.
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
- Reason
- Unapproved design changes to the products outside of the 510(k) clearance.
- Classification
- Class I
- 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/61dfefb1-7557-4e3a-a960-7088e742add8