Warning
Medline Industries Recalls Medline Convenience Kits containing select SKUs of 10mL
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1880-2026Medical Device
Medline Industries Recalls Medline Convenience Kits containing select SKUs of 10mL
Medline Industries, LP · Class II — Moderate Risk
Product Description
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
Reason for Recall
Unapproved design changes to the products outside of the 510(k) clearance.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Medline Industries, LP initiated the recall on February 27, 2026 affecting 270,311 total. Unapproved design changes to the products outside of the 510(k) clearance. The product was distributed internationally, including the United States. Consumers should check their purchases and discontinue use of any affected product. Contact Medline Industries, LP for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects and Medline Industries recalls.