Iantrek Inc. recalls Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterve…

Recall date

September 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0134-2026

FDA classification

Class II

Brand / firm

Iantrek Inc.

Sold / distributed

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.

Why it was recalled

Potential for compromised integrity of the sterile packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.