Baxter Trulight Surgical Lights Recalled for Thermal Skin Injuries
Baxter Healthcare Corporation recalled Trulight 5000/3000 Surgical Light systems due to customer reports of thermal skin injuries. The urgent medical device correction affects models 4038210 and 4038310 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: Customer reports of thermal skin injuries from a Class II medical device meet the rubric criterion for Severe severity: significant injury/property-damage reports on Class II devices.
Plain-English summary
Baxter Healthcare Corporation has issued an urgent medical device correction for Trulight 5000/3000 Surgical Light systems. The recall affects model numbers 4038210 (Duo Surgical Lights) and 4038310 (Trio/Quad Surgical Lights), as well as VidiaPort and Trulight product codes equipped with iLED 7 light-head systems.
The correction was issued following customer reports of thermal skin injuries during use of these surgical light systems. Thermal injuries represent a significant safety concern in the operating room environment.
The affected units have been distributed worldwide. Specific serial numbers have been provided to assist with identification of the impacted devices.
Healthcare facilities currently using these devices should contact Baxter Healthcare Corporation regarding the urgent correction and any necessary remediation measures.
The recalled product
- Product
- Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 5
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 (7)
- a) UDI/DI 00887761968400
- Serial Numbers: 107565745
- b) UDI/DI 00887761968394
- Serial Numbers: 107565746
- 107592673
- 107592675
- 108034069
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 injury
See all →- HighCASE cardiac testing systems may spark at the printer head
FDA (Devices) · 2026-06-10
- HighEndoscopy video processors recalled over hot light guide and thermal injury risk
FDA (Devices) · 2025-08-27
- HighVideo Colonoscope May Cause Thermal Burns to Tissue During Use
FDA (Devices) · 2025-03-05
- HighStryker iBur Surgical Bur Recall Due to Excessive Heat Risk
FDA (Devices) · 2024-09-04
- HighStryker iBur 3.0mm surgical burr recalled over thermal hazard
FDA (Devices) · 2024-09-04
Similar recalls
- HighTrumpf Ceiling Mounted Surgical Lighting Systems Recalled for Spring Arm Defect
FDA (Devices) · 2015-08-19
- HighBaxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Hazard
FDA (Devices) · 2024-10-30
- HighBaxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Risk
FDA (Devices) · 2024-10-30
- 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 electrical hazards
FDA (Devices) · 2024-10-30
- SevereBaxter TruSystem 7000 Operating Tables Recalled for Electrical Short-Circuits
FDA (Devices) · 2024-10-30