FDA Medical devices recall ·
CorNeat EverPatch recall
- Recall number
- Z-2537-2025
- Date
- (initiated October 16, 2024)
- Company / brand
- Corneat Vision, Ltd.
4, Ha-Sheizaf, Ra'Anana, N/A, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Why was it recalled?
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: G16010362950
Distribution
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.
States: Arizona California Colorado Delaware Florida Georgia Idaho Illinois Indiana Kansas Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina New York Ohio Pennsylvania Puerto Rico South Carolina Tennessee Texas Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2537-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.