C-Rex UNO Microinterventional Goniotomy Instrument — Class II medical device recall Z-0135-2026
Ongoing recall by Iantrek Inc., reported 2025-10-22, distributed nationwide. Potential for compromised integrity of the sterile packaging.
| Recall number | Z-0135-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iantrek Inc., Providence, RI, United States |
| Recall initiated | 2025-09-06 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 198 |
| Reason classes | sterility |
| Lot numbers | 351729, 351759 |
| Model numbers | CRX-120 |
| Expiration dates | 2026-05 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0135-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.