FDA DeviceClass IINotable

FDA Recall: Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Mod

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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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

2609 units

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