HIGH

Iantrek CycloPen CP-300 Cyclodialysis System Recalled for Sterile Packaging Integrity (2025)

Iantrek recalled 1,262 CycloPen CP-300 Cyclodialysis System units distributed nationwide to medical facilities. The recall stems from a potential compromise to sterile packaging integrity. Hospitals and clinics should stop using the device immediately and follow Iantrek’s recall instructions via email.

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

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About This Product

The CycloPen Microinterventional Cyclodialysis System CP-300 is a manual surgical instrument used in eye surgery to create or modify a cyclodialysis and deliver materials to reinforce the surgical site.

Why This Is Dangerous

A compromised sterile barrier may render the device non-sterile. Using a non-sterile instrument in intraocular surgery can increase the risk of infection and complications.

Industry Context

This recall is not described as part of a broader industry pattern in the provided notice.

Real-World Impact

Facilities may need to replace affected devices and review sterile-packaging controls. There is potential patient risk if non-sterile devices are used in procedures.

Practical Guidance

How to identify if yours is affected

  1. Confirm CP-300 model number on the device label
  2. Review UDIs and lot numbers to match those listed in the recall
  3. Check expiration dates 02/2026, 05/2026, or 06/2026
  4. Verify packaging integrity prior to any use

Where to find product info

Recall notices and device identifiers can be found on the FDA enforcement page linked in the recall record and the manufacturer communications

What timeline to expect

Hospitals and clinics should expect follow-up guidance from Iantrek; replacement or remediation timelines are not specified

If the manufacturer is unresponsive

  • Escalate to hospital compliance or regulatory affairs
  • Refer to FDA recall resources and file a report if needed

How to prevent similar issues

  • Inspect sterile packaging integrity before storing or using any surgical devices
  • Verify UDIs and lot numbers during procurement
  • Maintain strict recall monitoring for ophthalmic surgical devices

Documentation advice

Document the recall notice, model CP-300, UDIs, lot numbers, expiration dates, date of receipt, and all correspondence with Iantrek

Product Details

Brand: Iantrek. Product: CycloPen Microinterventional Cyclodialysis System CP-300. Model numbers: CP-300. UDI: +B962CP3000/$$7351645/16D20250201/14D20260201/Q1_, +B962CP3000/$$7351726/16D20250501/14D20260501/Q11, +B962CP3000/$$7351795/16D20250601/14D20260601/Q19. Lot numbers: 351645, 351726, 351795. Expiration dates: 02/2026, 05/2026, 06/2026. Quantity recalled: 1,262 units. Distribution: US nationwide in the states listed. Sold at: Unknown. Price: Unknown. Date sold: Unknown. Manufacturer country: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1,262 units recalled nationwide
  • Model CP-300 CP-300 identified in recall
  • UDI variants listed for CP-300 devices
  • Lot numbers: 351645, 351726, 351795
  • Expiration dates: 02/2026, 05/2026, 06/2026
  • Distribution: United States, nationwide to medical facilities

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Details

Brand
Model Numbers
CP-300
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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