Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-2315-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)

Product Classification:

Class II

Date Initiated: June 4, 2024

Date Posted: July 17, 2024

Recall Number: Z-2315-2024

Event ID: 94766

Reason for Recall:

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

Status: Ongoing

Product Quantity: 6243 units

Code Information:

All Serial Numbers: a) UDI/DI 00887761968325; b) UDI/DI 00887761968318; c) UDI/DI 00887761968301; d) UDI/DI 00887761968295; e) UDI/DI 00887761968288; f) UDI/DI 00887761968271

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated