Cyclodialysis surgical instruments recalled over compromised sterile packaging integrity
Iantrek is recalling 1,262 CycloPen Microinterventional Cyclodialysis Systems over the potential for compromised integrity of the sterile packaging.
What this means for you
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 CycloPen Microinterventional Cyclodialysis System, model CP-300, is being recalled. The device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis.
The recall concerns the potential for compromised integrity of the sterile packaging.
The recall covers 1,262 units, including lot 351645, 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
- Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of
- Manufacturer
- Iantrek Inc.
- Hazard
- sterile-barrier-breach
- packaging-defect
- infection-risk
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 (10)
- 1. Model Number CP-300
- UDI: +B962CP3000/$$7351645/16D20250201/14D20260201/Q1_
- Lot Number: 351645
- Exp date 02/2026. 2. Model Number CP-300
- UDI: +B962CP3000/$$7351726/16D20250501/14D20260501/Q11
- Lot Number 351726
- Exp date 05/2026. 3. Model Number CP-300
- UDI: +B962CP3000/$$7351795/16D20250601/14D20260601/Q19
- Lot Number 351795
- Exp date 06/2026.
Distribution
Distributed nationwide across the United States.
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