# FDA recall Z-0135-2026

> **Iantrek Inc.** · Class II · device recall initiated 2025-09-06.

## Product

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.

## Reason for recall

Potential for compromised integrity of the sterile packaging.

## Distribution

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.

## Key facts

- **Recall number:** Z-0135-2026
- **Recalling firm:** Iantrek Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-06
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Providence, RI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0135-2026

## Citation

> AI Analytics. FDA recall Z-0135-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0135-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*