Safety Alert: Class II: Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
healthClass IIRecalled on Sep 17, 2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
🔢 N/A
Sold At: CORNEAT VISION, LTD.(Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.)
Recall #: FDA-DEVICE-Z-2537-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- UDI-DI: G16010362950
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Summary
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact CORNEAT VISION, LTD. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.