Goniotomy instruments recalled over compromised sterile packaging integrity
Iantrek is recalling 198 C-Rex UNO Microinterventional Goniotomy Instruments over the potential for compromised integrity of the sterile packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: compromised sterile packaging on a surgical instrument creates an infection risk, and no injuries are reported.
Plain-English summary
The C-Rex UNO Microinterventional Goniotomy Instrument, model CRX-120, is being recalled. It is a sterile single-use disposable manual surgical instrument used in ophthalmic procedures.
The recall concerns the potential for compromised integrity of the sterile packaging.
The recall covers 198 units, including lot 351729, distributed across states including Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Jersey and New York. The FDA has classified the action as Class II.
The enforcement record describes the packaging issue and reports no injuries. Facilities should quarantine affected stock and follow Iantrek's instructions.
The recalled product
- 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…
- Manufacturer
- Iantrek Inc.
- Affected units
- 198
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 1. Model Number: CRX-120
- UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$
- Lot Number 351729
- Lot Number: 351759
- Exp date 05/2026.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Iantrek Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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