Quick Facts at a Glance
- Recall Date
- September 6, 2025
- Hazard Level
- HIGH
- Brand
- Iantrek
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Iantrek
- Product type
- Goniotomy Instrument
- Model numbers
- CRX-120, UDI:+B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$, UDI:+B962CRX1200/$$7351759/16D20250501/14D20260501/Q1%
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 6, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for compromised integrity of the sterile packaging.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Iantrek Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The C-Rex UNO Microinterventional Goniotomy Instrument CRX-120 is a sterile single-use disposable surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.
Why This Is Dangerous
If the sterile packaging is compromised, sterility cannot be guaranteed, potentially increasing the risk of infection during surgery.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
The issue could impact patient safety during eye surgery and may require rapid Instrument replacement to avoid infection risk.
Practical Guidance
How to identify if yours is affected
- Identify CRX-120 models with Lot 351729 or 351759.
- Confirm Exp date 05/2026 and verify UDI codes.
- Inspect packaging for integrity before opening.
Where to find product info
UDI codes on packaging and device labeling; Lot numbers and Exp date printed on the packaging.
What timeline to expect
Recall resolution timelines are determined by the manufacturer; typical processes may take weeks to months.
If the manufacturer is unresponsive
- Escalate to hospital procurement and contact FDA for guidance.
- Keep records of all communications and document affected lots.
How to prevent similar issues
- Verify sterile packaging integrity before use.
- Source sterile devices from authorized suppliers.
- Monitor for recall updates from FDA and manufacturer.
Documentation advice
Save all recall communications, photos of packaging, lot numbers, and dates; document device usage and patient consent in case of later review.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 198 units
- Model numbers/UDIs provided: CRX-120 with two UDIs
- US nationwide distribution to healthcare facilities
- Remedy: stop use and follow manufacturer instructions
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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