Iantrek recalls CycloPen Microinterventional Cyclodialysis System (model CP-300) due to potential compromised sterile packaging. Affected units have specific lot numbers and expiration dates. Consumers should contact Iantrek for details.
Potential for compromised integrity of the sterile packaging.
Iantrek is recalling its CycloPen Microinterventional Cyclodialysis System (model CP-300) because the sterile packaging might be damaged, increasing infection risk during surgery. This is a serious safety issue for medical procedures.
The sterile packaging of the CycloPen device might be compromised, which could lead to contamination during surgery. This increases the risk of infection for patients undergoing the procedure.
Medical professionals using the CycloPen device for surgical procedures are most at risk. Patients undergoing the specific surgeries that require this device could be affected if the packaging is compromised.
Check for model number CP-300 on the device. Look for lot numbers 351645, 351726, or 351795 with expiration dates of 02/2026, 05/2026, or 06/2026 respectively.
Identify the model number (CP-300) and lot number (351645, 351726, or 351795) to confirm if your device is affected.
The recall is due to potential compromised sterile packaging, which could increase infection risk during surgery. Affected devices should not be used until the issue is resolved.
Check for model number CP-300 and lot numbers 351645, 351726, or 351795 with expiration dates of 02/2026, 05/2026, or 06/2026 respectively.
Contact Iantrek directly for instructions on how to return or replace the device. The recall does not specify a deadline for action.
We’ve drafted a message you can send Iantrek to request your refund or repair — edit it as you like.
Subject: Recall Z-0134-2026 — Iantrek Iantrek Hello, I own a Iantrek that is covered by recall Z-0134-2026 from Iantrek. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
