Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0134-2026 — 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, b

U.S. FDA — Device Enforcement · United States · 2025-09-06 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0134-2026
Date of alert: 2025-09-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Iantrek Inc.
Product category: device
Product type: Devices

Reported risk: Potential for compromised integrity of the sterile packaging.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related