Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2537-2025·Announced 2025-09-17

Surgical matrix patches recalled for labeling correction on wound dehiscence management

CorNeat EverPatch permanent tissue-integrating surgical matrices are the subject of a retroactive labeling correction, following complaints, to include prevention and management of wound dehiscence.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers precautionary recalls; the action is a labeling correction rather than a defect described in the product.

Plain-English summary

The CorNeat EverPatch, REF 1036295, a permanent tissue-integrating surgical matrix measuring 5.0 mm by 6.5 mm by 100 microns, sterile EO and prescription only, UDI-DI G16010362950, is being recalled. Distribution was nationwide in the United States and internationally.

The action is retroactive and was taken, following complaints, as a labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of wound dehiscence. The FDA classified the action as Class II. The notice does not describe a defect in the product itself.

Surgical centres holding this product should follow the manufacturer's instructions for applying the updated labeling.

The recalled product

Product: CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Manufacturer: CORNEAT VISION, LTD.
Category: Medical Device — Ophthalmic Implant
Hazard: labeling-correction
surgical-matrix
class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI-DI: G16010362950

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Same manufacturer · CORNEAT VISION, LTD.

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Same hazard · labeling correction