Iantrek Inc.: Medical Device Recall in 2025 - (Recall #: Z-0135-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 6, 2025

Date Posted: October 22, 2025

Recall Number: Z-0135-2026

Event ID: 97640

Reason for Recall:

Potential for compromised integrity of the sterile packaging.

Status: Ongoing

Product Quantity: 198

Code Information:

1. Model Number: CRX-120; UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$; Lot Number 351729; Exp date 05/2026. 2. Model Number: CRX-120 UDI: +B962CRX1200/$$7351759/16D20250501/14D20260501/Q1%; Lot Number: 351759; Exp date 05/2026.

Distribution Pattern:

US Nationwide distribution in the states of 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.

Voluntary or Mandated:

Voluntary: Firm initiated