Iantrek Inc.: Device Recall
Recall #Z-0134-2026 · 09/06/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0134-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Iantrek Inc.
- Status
- Ongoing
- Date Initiated
- 09/06/2025
- Location
- Providence, RI, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,262 units
Reason for Recall
Potential for compromised integrity of the sterile packaging.
Product Description
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.
Distribution Pattern
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.
Other Recalls by Iantrek Inc.
- Class II: Risk 09/06/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.