# FDA recall Z-0134-2026

> **Iantrek Inc.** · Class II · device recall initiated 2025-09-06.

## 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.

## Reason for recall

Potential for compromised integrity of the sterile packaging.

## Distribution

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.

## Key facts

- **Recall number:** Z-0134-2026
- **Recalling firm:** Iantrek Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-06
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Providence, RI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0134-2026

## Citation

> AI Analytics. FDA recall Z-0134-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0134-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*