FDA DeviceClass IINotable

FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE G

Date: 2026-04-29

Brand: Medline Industries, LP

Category: Medical Device

FDA Class: Class II

Description

Unapproved design changes to the products outside of the 510(k) clearance.

Hazard

Unapproved design changes to the products outside of the 510(k) clearance.

Remedy

270,311 total

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