Ear, Nose, And Throat Surgical Tray

Recall Summary Three Medline ear, nose, and throat surgical kits are being recalled because certain components inside them—specifically control syringes, guidewires, and high-pressure tubing—no longer have valid FDA regulatory clearances. These kits were distributed nationwide across all U.S. states and Washington, D.C. The affected products are the ENT PACK (Model DYNJ59030B), ENT kit (Model DYNJ908586C), and LH 3 PORT W/O WASTEBAG (Model VASC1081C).

Product

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C

Reason

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Classification

Class I

Category

medical device recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-02-25

Status

Open, Classified

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

US Nationwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e15a0b80-68a2-49d7-bcc7-2eb2881c3045