FDA DeviceClass IINotable

FDA Recall: Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML

Date: 2026-04-29
Brand: Medline Industries, LP
Category: Medical Device
FDA Class: Class II

Description

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Hazard

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Remedy

38,230 units

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