Atlas FDA

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C

FDA device recall Z-1882-2026 · posted 2026-04-17 · Open, Classified

Recall details

Recalling firm
Medline Industries, LP
Reason for recall
Unapproved design changes to the products outside of the 510(k) clearance.
Action taken
On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
Root cause
Component change control
Status
Open, Classified
Product code
FTN
Quantity affected
270,311 total
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Date initiated
2026-02-27
Date posted
2026-04-17
Location
Northfield, IL

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