Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Trulight 5000/3000 Surgical Light Recalled by Baxter Healthcare Corporation Due to Baxter Healthcare Corporation is issuing an Urgent Medical...

Date: June 4, 2024
Company: Baxter Healthcare Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corporation directly.

Affected Products

Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)

Quantity: 5 units

Why Was This Recalled?

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads

Where Was This Sold?

Worldwide distribution.

About Baxter Healthcare Corporation

Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report