Quick Facts at a Glance
- Recall Date
- October 16, 2024
- Hazard Level
- HIGH
- Brand
- CorNeat Vision
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CorNeat Vision
- Product type
- Permanent Tissue-Integrating Surgical Matrix
- Model numbers
- G16010362950
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 16, 2024
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
The recall is retroactive and centers on labeling to include prevention and management of would dehiscence.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall may affect procurement and labeling workflows for procedures that use EverPatch; the data does not indicate injuries from the device itself.
Practical Guidance
How to identify if yours is affected
- Check packaging and documentation for REF 1036295 and UDI-DI G16010362950
- Confirm the device is EverPatch permanent tissue-integrating surgical matrix
- Note that product is prescription-only (RX) and SterileEO
- If in doubt, contact your healthcare provider or CORNEAT VISION, LTD.
Where to find product info
FDA enforcement report: Z-2537-2025 page linked in recall notice
What timeline to expect
Timeline for refund or replacement is not specified by the manufacturer
If the manufacturer is unresponsive
- Escalate with your hospital or surgical center's safety office
- Contact FDA or CPSC if the company is unresponsive
- Document all communications and retain copies of the recall notice
How to prevent similar issues
- Verify labeling for dehiscence prevention guidance in future devices
- Ask suppliers to confirm updated labeling before use
- Monitor for updates from CORNEAT VISION, LTD. and the FDA recall page
Documentation advice
Retain the recall notice, packaging, serial/UDI, and correspondence with the manufacturer or healthcare provider
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution; US states listed plus Argentina, Israel, Hong Kong
- Retroactive labeling correction to prevent dehiscence
- Package indicates SterileEO; RX only
- Active recall as of 2024-10-16; reported 2025-09-17
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