Stryker Communications recalls 40 surgical light systems nationwide after reports of stress lines in the powder coating. The devices include CH00000001 and the SLX to Oculan NFC Upgrade Kit, P60034. The recall is active as of July 15, 2025. Patients and healthcare providers should stop using the devices immediately and follow manufacturer recall instructions.
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Communications or your healthcare provider for instructions. Notification method: Letter
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Surgical lighting systems are used in operating rooms to illuminate surgical areas. These include modular light systems and upgrade kits.
Powder coating chipping can create surface debris and potential contamination issues near sterile fields.
This recall is not indicated as part of a broader industry pattern in the provided data.
Immediate halt in use may cause scheduling challenges but reduces contamination risks and potential device failure during procedures.
FDA recall page and the enforcement report linked in the data
Refund or replacement timelines not specified; expect manufacturer instructions via mailed notification
Keep copies of notification letters, model numbers, UDIs, and any correspondence with the manufacturer
Model numbers: CH00000001, P60034. UDI-DI: 07613327296167 and 07613327651317. Sold nationwide in the United States. No price data provided.
No specific injuries or incidents are detailed in the provided recall notice.
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