Plastic Surgery And Accessories Kit
Recall Summary Medline is recalling two Plastic Surgery and Accessories Kits (Face/Rhinoplasty Pack and Plastic Head-Neck Pack) that contain 10mL polycarbonate colored syringes because the syringes were modified in ways that were not approved by the FDA. These kits have been distributed nationwide across the US, as well as in Canada, Panama, and Barbados. This is a Class I recall, the most serious classification.
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
- 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/29192798-1582-4e4d-bcd3-2e1b4e359550