Class II — Steris Corporation
| Recalling firm | STERIS Corporation |
|---|---|
| Registered facility | Key Surgical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently. |
| 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. |
| Quantity | 140 units |
| Distribution | Worldwide Distribution - USA including Alabama, Alaska, Arkansas, California, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, and Virginia and Internationally to Canada, China, Greece, Indonesia, Republic of Korea, Romania, Russi… |
| Initiated | 2014-11-26 |
| Classified | 2015-01-06 |
| Terminated | 2015-07-11 |
| Recall number | Z-0930-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Steris Corporation (Z-0930-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69987/
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