Vortex Surgical recalled 14,789 Disposable Diamond Dusted ILM Elevators on December 16, 2025. The recall follows concerns about voids in the seal of Tyvek pouches, which could lead to bioburden contamination. Healthcare providers and patients should stop using the devices immediately.
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vortex Surgical Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled model is the Disposable Diamond Dusted ILM Elevator, catalog number 12-7523. It distributed worldwide, including 8,651 units in the U.S. The product was sold prior to the recall date.
The seal of the Tyvek pouches may have voids that compromise the sterile barrier. This defect poses a risk of bioburden contamination, potentially leading to infection.
No specific incidents of infection have been reported to date. The high hazard level indicates a serious risk to patients using these devices.
Stop using the Disposable Diamond Dusted ILM Elevator immediately. Follow the manufacturer’s instructions for returning the product and contact Vortex Surgical Inc. or your healthcare provider for further steps.
For more information, contact Vortex Surgical Inc. at their official website or via telephone. Recall instructions are provided in a notification letter.
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