Baxter iLED 7 surgical lights recalled due to thermal burn risk
Baxter Healthcare is recalling iLED 7 surgical lights due to customer reports of thermal skin injuries. The recall affects approximately 6,243 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall with explicitly reported thermal skin injuries. The rubric indicates FDA Class II recalls with reported significant injuries warrant a Severe rating.
Plain-English summary
Baxter Healthcare Corporation is recalling iLED 7 surgical light systems because customers have reported thermal skin injuries when using these products. The recall affects six models of surgical lights—Ceiling Single, Mobile, Pendant, Ceiling Duo, Ceiling Trio, and Ceiling Quad—as well as specific VidiaPort and Trulight product codes equipped with iLED 7 light-heads.
A total of 6,243 units have been distributed worldwide. More information about this recall is available from the FDA and Baxter Healthcare Corporation.
The recalled product
- Product
- 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…
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 6,243
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Same hazard · thermal burn
See all →- SevereBaxter VidiaPort and Trulight surgical lights recalled for thermal burn risk
FDA (Devices) · 2024-07-17
- High
- HighJacuzzi and Sundance Hot Tubs Recalled for Thermal Burn Hazards
CPSC · 2022-12-15
- High
- HighCovidien Sonicision Surgical Generator Recalled for Manufacturing Defect Risk
FDA (Devices) · 2021-08-18
Similar recalls
- HighMaquet PowerLED 700 Surgical Light Recall Due to Detaching Module
FDA (Devices) · 2014-06-18
- HighTrumpf Ceiling Mounted Surgical Light Systems Recalled for Falling Hazard
FDA (Devices) · 2016-01-06
- HighTrumpf Ceiling Mounted Surgical Lighting Systems Recalled for Spring Arm Defect
FDA (Devices) · 2015-08-19
- HighMaquet Surgical Light Suspension Arms Recalled for Debris Risk
FDA (Devices) · 2015-07-15
- HighBaxter Operating Table TruSystem 7000 V Recalled for Battery Short-Circuit Risk
FDA (Devices) · 2024-10-30
- HighBaxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Risk
FDA (Devices) · 2024-10-30