Stryker Communications: Medical Device Recall in 2019 - (Recall #: Z-1388-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.

Product Classification:

Class II

Date Initiated: November 13, 2018

Date Posted: May 29, 2019

Recall Number: Z-1388-2019

Event ID: 82476

Reason for Recall:

There is a potential the joint in the suspension of the device is insufficiently assembled.

Status: Ongoing

Product Quantity: 3,176 devices

Code Information:

Serial numbers 100000000065406 to 100000000106685.

Distribution Pattern:

Distribution was nationwide, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, France, India, Japan, Korea, Mexico, Netherlands, Spain and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated