Harmony¿ vLED Surgical Lighting System — Class II medical device recall Z-0930-2015
Terminated recall by Steris Corporation, reported 2015-01-14, distributed in AK, AL, AR, CA, DC, FL, IL, IN…. STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inc
| Recall number | Z-0930-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2014-11-26 |
| Classified | 2015-01-06 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-07-11 |
| Distributed | AK, AL, AR, CA, DC, FL, IL, IN, KS, LA, MS, NC, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA |
| Countries outside the US | CA, CN, GR, ID, KR, RO, TW, VN |
| Quantity | 140 units |
Product
Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
Reason for recall
STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
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-0930-2015. 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.