FDA Device recall Z-2314-2024
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights} by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2314-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-04 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Reason
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
Identifiers
| code_info | a) UDI/DI 00887761968400, Serial Numbers: 107565745; b) UDI/DI 00887761968394, Serial Numbers: 107565746, 107592673, 107592675, 108034069 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2314-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.