Steris Corporation: Medical Device Recall in 2015 - (Recall #: Z-0930-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 26, 2014

Date Posted: January 14, 2015

Recall Number: Z-0930-2015

Event ID: 69987

Reason for Recall:

STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.

Status: Terminated

Product Quantity: 140 units

Code Information:

The following item numbers are included in this recall: B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.

Distribution Pattern:

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, Russian Federation, Taiwan, and Viet Nam.

Voluntary or Mandated:

Voluntary: Firm initiated