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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Iantrek
- Product type
- Cyclodialysis System CP-300 Instrument
- Model numbers
- CP-300
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 6, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Confirm CP-300 model number on the device label
- Review UDIs and lot numbers to match those listed in the recall
- Check expiration dates 02/2026, 05/2026, or 06/2026
- 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
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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
- Distribution: United States, nationwide to medical facilities
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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