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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Baxter Healthcare Corporation: iLED 7 Surgical Lights Recalled Due to Thermal Skin Injury Risk

Agency Publication Date: July 5, 2024
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Summary

Baxter Healthcare Corporation has issued an urgent correction for approximately 6,523 iLED 7 surgical light systems and related carrying arms. The recall was initiated following customer reports of thermal skin injuries—specifically burns—occurring during medical procedures. The affected equipment includes the iLED 7 surgical lights, as well as VidiaPort and Trulight systems that are equipped with iLED 7 light-heads.

Risk

The surgical lights can generate excessive heat that may result in thermal skin injuries or burns to patients during surgery. Reports of such injuries have been confirmed, posing a direct physical hazard to patients in clinical settings.

What You Should Do

  1. Check your surgical light equipment for model numbers 4028110, 4028210, 4028310 (VidiaPort), 4038210, 4038310 (Trulight), and 4068110, 4068120, 4068140, 4068210, 4068310, 4068410 (iLED 7).
  2. Verify your specific unit by locating the UDI/DI or serial number on the device; for example, VidiaPort serial numbers include 108664155 and 108592036, while Trulight serial numbers include 107565745 and 108034069.
  3. Review the 'Urgent Medical Device Correction' letter sent by Baxter Healthcare Corporation for specific safety precautions and operational adjustments.
  4. Contact your healthcare provider or Baxter Healthcare Corporation directly for further instructions regarding technical support and potential remediation of the thermal heat issue.
  5. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Urgent Medical Device Correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: VidiaPort carrying arm, mount for auxiliary products (Ceiling Single/Duo/Trio Surgical Light)
Model / REF:
4028110
4028210
4028310
UPC Codes:
00887761968523
00887761968462
00887761968455
Lot Numbers (275):
108664155
108664156
108669683
108669684
108673461
108696617
108726885
108731089
108746956
108754496
108754497
108821898
108835099
108907603
108909646
108917888
108919439
108919440
108919441
108961413
108961414
108970453
108970454
108645027
108645028
108645031
108648403
108652874
108664909
108664911
108665618
108669680
108669681
108669682
108671489
108671494
108671495
108671496
108671497
108671498
108671499
108671500
108674055
108674056
108674057
108674058
108676619
108676620
108676621
108677352
Product: Trulight 5000/3000 Surgical Light (Duo/Trio/Quad)
Model / REF:
4038210
4038310
UPC Codes:
00887761968400
00887761968394
Lot Numbers:
107565745
107565746
107592673
107592675
108034069
Product: iLED 7 surgical lights (Ceiling Single/Mobile/Pendant/Duo/Trio/Quad)
Model / REF:
4068110
4068120
4068140
4068210
4068310
4068410
UPC Codes:
00887761968325
00887761968318
00887761968301
00887761968295
00887761968288
00887761968271
Lot Numbers:
All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94766
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 3 products (275 units; 5 units; 6243 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.