Iantrek Inc. recalls C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product…

Potential for compromised integrity of the sterile packaging.

C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.

Iantrek notified consignees on 09/06/2025 via email. Consignees were instructed to immediately remove and quarantine all affected units to prevent their use, notify personnel or customers if affected units were forwarded to other facilities. Consignees may also alternatively provide Iantrek with contact information so that they can notify them on the customer's behalf. An Iantrek representative will be contacting each consignee immediately to help facilitate removal, return and replacement of affected units. They will arrange to have replacement product shipped to consignees at no cost.

• FDA enforcement recordOfficial FDA database entry for Z-0135-2026
• FDA device classification · HMZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.4350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Iantrek Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.