FDA Medical devices recall ·
Cyclopen Microinterventional Cyclodialysis System recall
- Recall number
- Z-0134-2026
- Date
- (initiated September 6, 2025)
- Company / brand
- Iantrek Inc.
216 Weybosset St Ste 2, Providence, RI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,262 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft.
Why was it recalled?
Potential for compromised integrity of the sterile packaging.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
States: Alabama Arizona California Connecticut Delaware Florida Georgia Idaho Illinois Maryland Michigan Minnesota Missouri Mississippi Nebraska New Jersey New York Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0134-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.