Trulight 5000/3000 Surgical Light — Class II medical device recall Z-2314-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-07-17. Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of therma
| Recall number | Z-2314-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-06-04 |
| Classified | 2024-07-05 |
| Reported by FDA | 2024-07-17 |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 00887761968394, 00887761968400 |
| Serial numbers | 107565745, 107565746, 107592673, 107592675, 108034069 |
Product
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2314-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.