FDA DeviceClass IINotable

FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK D

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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