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Use caution Medical device recall · FDA · Published June 4, 2024

Baxter Trulight 5000/3000 Surgical Lights: Risk of Thermal Skin Injuries

Baxter recalls Trulight 5000/3000 surgical lights with specific model numbers due to reported thermal skin injuries. Affected units include Duo and Trio/Quad models with listed serial numbers.

🇺🇸 FDA recall #Z-2314-2024Medical deviceBaxter ›
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Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

Baxter is recalling Trulight 5000/3000 surgical lights that have been reported to cause thermal skin injuries. This recall affects specific model numbers and serial numbers used in surgical settings. Read more at govinfonow.com/recall/54925-baxter-trulight-5000-3000-surgical-lights-risk-of-thermal-skin.

Source Summary by GovInfoNow · govinfonow.com/recall/54925-baxter-trulight-5000-3000-surgical-lights-risk-of-thermal-skin · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2314-2024

Cite this page

“Baxter Trulight 5000/3000 Surgical Lights: Risk of Thermal Skin Injuries.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54925-baxter-trulight-5000-3000-surgical-lights-risk-of-thermal-skin. Based on FDA recall #Z-2314-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2314-2024%22&limit=1).

The FDA announced on June 4, 2024, that Baxter Healthcare Corporation is recalling Trulight 5000/3000 Surgical Lights due to reports of thermal skin injuries. This voluntary Class II recall affects specific model numbers and serial numbers distributed worldwide.

How to tell if you have it

  • Trulight 5000/3000 Surgical Light, model number 4038210 (Duo Surgical Lights), UDI/DI 00887761968400, Serial Number 107565745
  • Trulight 5000/3000 Surgical Light, model number 4038310 (Trio/Quad Surgical Lights), UDI/DI 00887761968394, Serial Numbers 107565746, 107592673, 107592675, 108034069

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. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads.

Context

GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since September 2, 2015. Other recent recalls of similar products include Lutronic DermaV Laser System Recall (August 6, 2026), Stryker CHROMOPHARE Softlit Ring Surgical Light Recall (February 23, 2026), and I.T.S. DUL/UOL Systems Risk MRI Heating - Recall (January 23, 2026).

How to tell if you have this one

Check for model numbers 4038210 (Duo Surgical Lights) or 4038310 (Trio/Quad Surgical Lights). Affected units have specific serial numbers: 107565745 for model 4038210 and 107565746, 107592673, 107592675, 108034069 for model 4038310.

  • Brand
    Baxter
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2313-2024VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights); a) UDI/DI 00887761968523, Serial Numbers: 108664155, 108664156, 108669683, 108669684, 108673461, 108696617, 108726885, 108731089, 108746956, 108754496, 108754497, 108821898, 108835099, 108907603, 108909646, 108917888, 108919439, 108919440, 108919441, 108961413, 108961414, 108970453, 108970454; b) UDI/DI 00887761968462, Serial Numbers: 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, 108677353, 108678974, 108678975, 108680874, 108680875, 108680877, 108683306, 108692868, 108696905, 108698871, 108712900, 108713005, 108724511, 108724512, 108726889, 108726890, 108726969, 108726970, 108729819, 108729820, 108729821, 108729822, 108740036, 108740037, 108741241, 108741242, 108741243, 108741244, 108741245, 108741246, 108746957, 108746958, 108750621, 108750622, 108750623, 108750624, 108750625, 108753175, 108753176, 108753177, 108753178, 108753179, 108766308, 108766309, 108766310, 108766311, 108768265, 108773362, 108773388, 108773389, 108776596, 108776597, 108776598, 108776599, 108784862, 108784865, 108784866, 108784867, 108784868, 108786548, 108786549, 108786550, 108786551, 108786552, 108786553, 108798264, 108799126, 108799128, 108799129, 108799130, 108799131, 108799132, 108799133, 108806749, 108806750, 108806751, 108806752, 108817691, 108817693, 108817694, 108823304, 108826291, 108826292, 108826293, 108826294, 108826295, 108826296, 108832044, 108835017, 108835018, 108835019, 108835020, 108835100, 108835102, 108835103, 108877191, 108877192, 108886196, 108886197, 108886204, 108886205, 108886206, 108886207, 108886208, 108886209, 108891278, 108892971, 108896990, 108909639, 108909640, 108914098, 108914100, 108917065, 108917882, 108917883, 108917891, 108917892, 108917893, 108917894, 108926822, 108926823, 108927498, 108927506, 108927508, 108927509, 108927511, 108938126, 108938128, 108938130, 108952802, 108952803, 108952804, 108952805, 108954128, 108957452, 108957453, 108957454, 108957455, 108959400, 108959401, 108959402, 108959403, 108959404, 108959405, 108961409, 108961410, 108961411, 108961412, 108965179, 108965180, 108965181, 108965182, 108965183, 108970447, 108970448, 108970449, 108970450, 108970451, 108970452, 108970455, 108970456, 108970457, 108973043, 109042912, 109042913, 109042914, 109042915, 109042916, 109042917, 109042918, 109042919, 109042920, 109042921, 109042922, 109042923; c) UDI/DI 00887761968455, Serial Numbers: 108592036, 108611920, 108619324, 108648397, 108648399, 108653145, 108664152, 108665620, 108671478, 108671479, 108671488, 108757703, 108778413, 108784863, 108832046, 108832147, 108835101, 108892991, 108896993, 108896994, 108917886, 108917889, 108933948, 108933952, 108933958, 108941393, 108941394, 108941395, 108941397, 108949663, 108949664, 108949665, 108949666, 108949667, 108949668, 108966760, 108966761, 108966762, 108966763, 108966764, 108966765, 108966766, 108966767, 108973046, 108973047, 108973048, 108973049, 108978929, 108982386, 108982387275 units
Z-2314-2024Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights); a) UDI/DI 00887761968400, Serial Numbers: 107565745; b) UDI/DI 00887761968394, Serial Numbers: 107565746, 107592673, 107592675, 1080340695 units
Z-2315-2024iLED 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); 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 008877619682716243 units
Based on the official FDA remedy

What to do — step by step

  1. Check Model Numbers

    Identify if your Trulight 5000/3000 surgical light has model numbers 4038210 or 4038310.

  2. Contact Baxter

    Reach out to Baxter Healthcare Corporation for assistance with the recall process.

How this recall unfolded

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Jun 4, 202412. FDA classified it Class II: Jul 5, 202423. Published in FDA’s Enforcement Report: Jul 17, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2314-2024 (June 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2314-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA