Steris Corporation 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Steris Corporation
Lot Codes / Batch Numbers
The following item numbers are included in this recall: B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.
Products Sold
The following item numbers are included in this recall: B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.
Steris Corporation is recalling Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighti due to STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AR, CA, FL, IL, IN, KS, LA, MS, NV, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, DC, PR
Page updated: Jan 19, 2026