Cyclopen Microinterventional Cyclodialysis System — Class II medical device recall Z-0134-2026
Ongoing recall by Iantrek Inc., reported 2025-10-22, distributed nationwide. Potential for compromised integrity of the sterile packaging.
| Recall number | Z-0134-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iantrek Inc., Providence, RI, United States |
| Recall initiated | 2025-09-06 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 1,262 units |
| Reason classes | sterility |
| Lot numbers | 351645, 351726, 351795 |
| Model numbers | CP-300 |
| Expiration dates | 2026-02, 2026-05, 2026-06 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0134-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.