FDA Device recall Z-0135-2026
C-Rex UNO Microinterventional Goniotomy Instrument
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of C-Rex UNO Microinterventional Goniotomy Instrument by Iantrek, citing potential for compromised integrity of the sterile packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0135-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-06 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Iantrek |
| Distribution | US |
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
Potential for compromised integrity of the sterile packaging.
Identifiers
| code_info | 1. Model Number: CRX-120; UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$; Lot Number 351729; Exp date 05/2026.…1. Model Number: CRX-120; UDI: +B962CRX1200/$$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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0135-2026%22
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