FDAJune 4, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

baxter healthcarebaxter

UPCs

0088776196840000887761968394

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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