TL 5000/3000 – Surgical LightRecalls & reported problems across all models
Baxter Medical Systems GmbH + Co. KG · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one TL 5000/3000 – Surgical Light model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of TL 5000/3000 – Surgical Light by Baxter Medical Systems GmbH + Co. KG in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2025 and Aug 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
TL 5000/3000 – Surgical Light recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 4, 2024Open, Classified
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
Z-2314-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported TL 5000/3000 – Surgical Light problems
Device problems
- Detachment of Device or Device Component1
- Device Fell1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
TL 5000/3000 – Surgical Light models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TL 5000/3000 – Surgical Light 4038310Lamp, operating-room1 recall1 report
- TL 5000/3000 – Surgical Light 4038210Lamp, surgical1 recall1 report
Recent TL 5000/3000 – Surgical Light adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2025Device Fell; Device Fell
BAXTER RECEIVED A REPORT STATING THAT TRULIGHT 5510 CAP DETACHED FROM THE SPRING ARM. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841607 ↗MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TRULIGHT TRIO HAD AN ISSUE, DUAL MONITOR SUPPORT SEPARATED FROM THE BOOM AND IS RESTING ON THE OPERATING ROOM TABLE. ADDITIONALLY, THE LIGHT FIXTURE SEPARATED FROM THE BOOM AND FELL DAMAGING THE FIXTURE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22132961 ↗
Other Baxter Medical Systems GmbH + Co. KG products
All Baxter Medical Systems GmbH + Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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