The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1388-2019·Announced 2019-05-29

Stryker Visum LED Surgical Lighting System Component Recall

Stryker is recalling 3,176 EDS Light Suspension components for the Visum LED Surgical Lighting System due to a potential assembly defect in the joint.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a surgical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Stryker Communications is recalling 3,176 units of the EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System. The recall involves specific catalog numbers including 0682001286, 0682001298, 0682001299, 0682001300, 0682001432, 0682001433, 0682001434, and 0682001435. The affected serial numbers range from 100000000065406 to 100000000106685.

The recall was initiated because there is a potential that the joint in the suspension of the device is insufficiently assembled. This component is intended to illuminate the operative site during surgical procedures with high-intensity light.

Distribution was nationwide, including Puerto Rico, and included government/military distribution. Foreign distribution was made to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, France, India, Japan, Korea, Mexico, Netherlands, Spain, and the United Kingdom. Users should contact Stryker Communications for further instructions regarding the recall.

The recalled product

Product
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…
Manufacturer
Stryker Communications
Category
Medical Device — Surgical Lighting
Hazard
Affected units
3,176

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial numbers 100000000065406 to 100000000106685.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Stryker Communications

See all →

Same hazard · structural defect

See all →

Similar recalls