HIGH

Iantrek Recalls Cyclopen Microinterventional System Over Sterility Risk

Iantrek recalled 1,262 units of the Cyclopen Microinterventional Cyclodialysis System on September 6, 2025. The recall stems from a risk of compromised sterile packaging that could affect patient safety. Health care providers and patients must stop using the device immediately and follow manufacturer instructions.

Quick Facts at a Glance

Recall Date
September 6, 2025
Hazard Level
HIGH
Brand
Iantrek
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Potential for compromised integrity of the sterile packaging.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Iantrek Inc. or your healthcare provider for instructions. Notification method: E-Mail

Product Details

The recalled product is the Cyclopen Microinterventional Cyclodialysis System, Model Number CP-300. It was distributed nationwide in various states, including California and Texas. The product is classified as a Class II medical device.

The Hazard

The recall involves a potential risk due to compromised integrity of the sterile packaging. This issue may lead to infections or other complications during surgical procedures.

Reported Incidents

There are no reported incidents or injuries related to this recall as of the report date. The FDA has classified the hazard level as high.

What to Do

Patients and healthcare providers should stop using the device immediately. Contact Iantrek Inc. or your healthcare provider for further instructions.

Contact Information

For more information, contact Iantrek Inc. via email or visit their official website. More details are also available at the FDA recall page.

Key Facts

  • Quantity recalled: 1,262 units
  • Recall date: September 6, 2025
  • Hazard level: High
  • Affected states: 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
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSurgical Instrument
Sold At
Multiple Retailers

Product Details

Brand
Iantrek
Model Numbers
1. Model Number CP-300
UDI: +B962CP3000/$$7351645/16D20250201/14D20260201/Q1_
Lot Number: 351645
Exp date 02/2026. 2. Model Number CP-300
UDI: +B962CP3000/$$7351726/16D20250501/14D20260501/Q11
+5 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more