CLASS II ONGOING Device recall · Reported 15 Oct 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 18 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots/ UDI: G16010362950

Quantity recalled630 units

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-0039-2026
FDA event ID: 97463
Recalling firm: Corneat Vision, Ra'Anana
Classification: Class II
Status: Ongoing
Recall initiated: 18 Aug 2025
FDA classified: 3 Oct 2025
Reported: 15 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

18 Aug 2025	Recall initiated by company
3 Oct 2025	Classified by FDA	+46 days
15 Oct 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

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Product as listed by the FDA

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

Where it was distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.

Nationwide Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Idaho Illinois Indiana Kansas Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina New York

Questions about this recall

Why was it recalled?

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Which lots are affected?

All Lots/ UDI: G16010362950

Where was it sold?

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.

Other products in this recall event

1 other product · FDA event 97463

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025	CLASS II	EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix recalled	Corneat Vision	Other	Nationwide

More recalls from Corneat Vision

All 3

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Device	CLASS II	EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix recalled	Corneat Vision	Other	Nationwide
17 Sep 2025Device	CLASS II	CorNeat EverPatch recalled by Corneat Vision	Corneat Vision	Other	Nationwide

Other Surgical Instruments recalls

All 3,883

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy	Karl Storz Endoscopy	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled	ASP Global	Device Malfunction	Nationwide