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Iantrek Inc. recalls Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinter
Recalled October 22, 2025 · FDA recall Z-0134-2026 · Iantrek
Hazard
Potential for compromised integrity of the sterile packaging. · FDA Class II
Units
1,262 units
Sold at
US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Description
Potential for compromised integrity of the sterile packaging.
Product
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft.
Manufacturer(s)
Iantrek Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →