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.
There is a potential the joint in the suspension of the device is insufficiently assembled.
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.
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.
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.
Check for catalog numbers: 0682001286, 0682001298, 0682001299, 0682001300, 0682001432, 0682001433, 0682001434, or 0682001435. The product was sold with serial numbers from 100000000065406 to 100000000106685.
Identify if your EDS Light Suspension has one of the listed catalog numbers: 0682001286, 0682001298, 0682001299, 0682001300, 0682001432, 0682001433, 0682001434, or 0682001435.
Ensure your product's serial number falls between 100000000065406 and 100000000106685.
The recall is due to a potential issue with the joint assembly in the EDS Light Suspension components, which could cause the surgical lighting system to malfunction during procedures.
Check if your EDS Light Suspension has one of the listed catalog numbers or a serial number in the range 100000000065406 to 100000000106685. If affected, contact Stryker for further instructions.
The recall states there is a potential for the joint to be insufficiently assembled, which could lead to lighting system failure during surgery. However, no specific injuries have been reported.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1388-2019 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1388-2019 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
