Reported Oct 22, 2025 · Ongoing
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen…
Iantrek Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Iantrek Inc. · 216 Weybosset St Ste 2 · Providence, RI · 02903-3734
Is this the product you have?
- Cyclopen Microinterventional Cyclodialysis System
- Model NumberCP-300
- Product DescriptionThe 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
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published CP-300UDI: +B962CP3000/$$7351645/16D20250201/14D20260201/Q1_; Lot Number: 351645; Exp date 02/2026. CP-300UDI: +B962CP3000/$$7351726/16D20250501/14D20260501/Q11; Lot Number 351726; Exp date 05/2026. CP-300UDI: +B962CP3000/$$7351795/16D20250601/14D20260601/Q19; Lot Number 351795; Exp date 06/2026. - Amount recalled
- 1,262 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential for compromised integrity of the sterile packaging.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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