CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
CorNeat EverPatch recalled by Corneat Vision
Corneat Vision is recalling CorNeat EverPatch, distributed nationwide in the US. The recall was initiated on 16 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2537-2025
- FDA event ID
- 97281
- Recalling firm
- Corneat Vision, Ra'Anana, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Oct 2024
- FDA classified
- 5 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 16 Oct 2024 | Recall initiated by company | |
| 5 Sep 2025 | Classified by FDA | +324 days |
| 17 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Product as listed by the FDA
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoDelawareFloridaGeorgiaIdahoIllinoisIndianaKansasMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNew YorkOhioPennsylvania
Questions about this recall
Why was it recalled?
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Which lots are affected?
UDI-DI: G16010362950
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Corneat Vision
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix recalled | Corneat Vision | Other | Nationwide |
| Device | CLASS II | CorNeat EverPatch recalled by Corneat Vision | Corneat Vision | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
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| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |