Data Foundry

Medical device recalls 2024

iLED 7 surgical lights — Class II medical device recall Z-2315-2024

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 numberZ-2315-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2024-06-04
Classified2024-07-05
Reported by FDA2024-07-17
Quantity6,243 units
UPC / GTIN / UDI-DI00887761968271, 00887761968288, 00887761968295, 00887761968301, 00887761968318, 00887761968325

Product

iLED 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)

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-2315-2024. 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.