Iantrek CycloPen and C-Rex UNO Instruments Recalled for Sterile Packaging

Agency Publication Date: October 10, 2025

Summary

Iantrek Inc. is recalling 1,460 surgical instruments, including the CycloPen Microinterventional Cyclodialysis System and the C-Rex UNO Microinterventional Goniotomy Instrument. Approximately 1,262 units of the CycloPen and 198 units of the C-Rex UNO are affected by this recall. The manufacturer initiated this action because the sterile packaging for these instruments may be compromised, meaning the tools might not be sterile when used in surgery.

Risk

If the sterile packaging is damaged or not properly sealed, the instruments may become contaminated with bacteria or other harmful pathogens. Using a non-sterile instrument during ophthalmic (eye) surgery poses a significant risk of infection and potential vision complications for the patient.

What You Should Do

This recall affects Iantrek CycloPen Microinterventional Cyclodialysis Systems (Model CP-300) and C-Rex UNO Microinterventional Goniotomy Instruments (Model CRX-120) with lot numbers 351645, 351726, 351795, 351729, and 351759.
Stop using the recalled surgical instruments immediately and remove them from your active inventory.
Examine your supplies to identify the affected lot numbers, which can be found on the product packaging and labels.
Contact the manufacturer, Iantrek Inc., or your authorized distributor to arrange for the return, replacement, or correction of any affected devices you have in stock.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for more information or to report any adverse events associated with these devices.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Cyclopen Microinterventional Cyclodialysis System

Model / REF:

CP-300

Lot Numbers:

351645 (Exp 02/2026)

351726 (Exp 05/2026)

351795 (Exp 06/2026)

UDI:

+B962CP3000

Quantity affected: 1,262 units. Detailed UDI strings include +B962CP3000/$$7351645/16D20250201/14D20260201/Q1_, +B962CP3000/$$7351726/16D20250501/14D20260501/Q11, and +B962CP3000/$$7351795/16D20250601/14D20260601/Q19.

Product: C-Rex UNO Microinterventional Goniotomy Instrument

Model / REF:

CRX-120

Lot Numbers:

351729 (Exp 05/2026)

351759 (Exp 05/2026)

UDI:

+B962CRX1200

Quantity affected: 198 units. Detailed UDI strings include +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$ and +B962CRX1200/$$7351759/16D20250501/14D20260501/Q1%.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97640

Status: Active

Manufacturer: Iantrek Inc.

Sold By: Hospitals; Surgical Centers; Ophthalmic Clinics; Medical Distributors

Manufactured In: United States

Units Affected: 2 products (1,262 units; 198)

Distributed To: Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Iantrek CycloPen Microinterventional Cyclodialysis Systems (Model CP-300) and C-Rex UNO Microinterventional Goniotomy Instruments (Model CRX-120) with lot numbers 351645, 351726, 351795, 351729, and 351759.

Stop using the recalled surgical instruments immediately and remove them from your active inventory.

Examine your supplies to identify the affected lot numbers, which can be found on the product packaging and labels.

Contact the manufacturer, Iantrek Inc., or your authorized distributor to arrange for the return, replacement, or correction of any affected devices you have in stock.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for more information or to report any adverse events associated with these devices.

Affected Products

Product: Cyclopen Microinterventional Cyclodialysis System

Model / REF:

CP-300

Lot Numbers:

351645 (Exp 02/2026)

351726 (Exp 05/2026)

351795 (Exp 06/2026)

UDI:

+B962CP3000

Product: C-Rex UNO Microinterventional Goniotomy Instrument

Model / REF:

CRX-120

Lot Numbers:

351729 (Exp 05/2026)

351759 (Exp 05/2026)

UDI:

+B962CRX1200

Quantity affected: 198 units. Detailed UDI strings include +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$ and +B962CRX1200/$$7351759/16D20250501/14D20260501/Q1%.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97640

Status: Active

Manufacturer: Iantrek Inc.

Sold By: Hospitals; Surgical Centers; Ophthalmic Clinics; Medical Distributors

Manufactured In: United States

Units Affected: 2 products (1,262 units; 198)