Stryker EDS Light Suspension Recall: Insufficient Joint Assembly Risk
Stryker recalls EDS Light Suspension components for potential insufficient joint assembly, risking surgical lighting system failure during procedures. Affected units include specific catalog numbers and serial ranges.
Use caution until it’s fixed
There is a potential the joint in the suspension of the device is insufficiently assembled.
Contact the company
What happened, in plain English
Stryker is recalling certain EDS Light Suspension components used in their surgical lighting systems due to a potential issue with the joint assembly. This could lead to the lighting system failing during surgery if the joint is not properly assembled. Read more at govinfonow.com/recall/69479-stryker-eds-light-suspension-recall-insufficient-joint-assembly-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69479-stryker-eds-light-suspension-recall-insufficient-joint-assembly-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1388-2019
Cite this page
“Stryker EDS Light Suspension Recall: Insufficient Joint Assembly Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69479-stryker-eds-light-suspension-recall-insufficient-joint-assembly-risk. Based on FDA recall #Z-1388-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1388-2019%22&limit=1).
Why it’s dangerous
The joint in the suspension may not be assembled correctly, which could cause the lighting system to malfunction during surgery. This might result in inadequate illumination of the surgical site, potentially affecting the procedure.
Who’s affected
Surgical teams using the Stryker Visum LED Surgical Lighting System with the recalled EDS Light Suspension components are most at risk. Patients undergoing surgery with these specific components may face lighting system failure.
How to tell if you have this one
Check for catalog numbers: 0682001286, 0682001298, 0682001299, 0682001300, 0682001432, 0682001433, 0682001434, or 0682001435. The product was sold with serial numbers from 100000000065406 to 100000000106685.
- Brand
Stryker- Category
Medical device
What to do — step by step
Check Product Catalog Numbers
Identify if your EDS Light Suspension has one of the listed catalog numbers: 0682001286, 0682001298, 0682001299, 0682001300, 0682001432, 0682001433, 0682001434, or 0682001435.
Verify Serial Number Range
Ensure your product's serial number falls between 100000000065406 and 100000000106685.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1388-2019 (November 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1388-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.