CorNeat Vision recalled EverPatch surgical matrix (REF 1036295) in a worldwide distribution that includes 50 states and several countries. The recall addresses retroactive labeling corrections to include prevention and management of would dehiscence. Healthcare providers and patients should stop using the device and follow the manufacturer's recall instructions.
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CORNEAT VISION, LTD. or your healthcare provider for instructions. Notification method: E-Mail
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EverPatch is a sterile, prescription-only surgical matrix used to support tissue healing. It measures 5.0 mm x 6.5 mm x 100 μm.
The recall is retroactive and centers on labeling to include prevention and management of would dehiscence.
This recall is not described as part of a broader industry pattern.
The recall may affect procurement and labeling workflows for procedures that use EverPatch; the data does not indicate injuries from the device itself.
FDA enforcement report: Z-2537-2025 page linked in recall notice
Timeline for refund or replacement is not specified by the manufacturer
Retain the recall notice, packaging, serial/UDI, and correspondence with the manufacturer or healthcare provider
Model numbers: UDI-DI: G16010362950. Sold worldwide, including US states listed in the recall and countries Argentina, Israel, and Hong Kong. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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