CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

The CycloPen Microinterventional Cyclodialysis device recalled

Iantrek is recalling The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument, distributed nationwide in the US. The recall was initiated on 6 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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.

Quantity recalled1,262 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0134-2026
FDA event ID: 97640
Recalling firm: Iantrek, Providence, RI
Classification: Class II
Status: Ongoing
Recall initiated: 6 Sep 2025
FDA classified: 10 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

6 Sep 2025	Recall initiated by company
10 Oct 2025	Classified by FDA	+34 days
22 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for compromised integrity of the sterile packaging.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arizona California Connecticut Delaware Florida Georgia Idaho Illinois Maryland Michigan Minnesota Missouri Mississippi Nebraska New Jersey New York Ohio Oklahoma Oregon

Questions about this recall

Why was it recalled?

Potential for compromised integrity of the sterile packaging.

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97640

This product is part of a recall event; the main page for the event is The C-Rex UNO Microinterventional Goniotomy Instrument recalled.

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025	CLASS II	The C-Rex UNO Microinterventional Goniotomy Instrument recalled	Iantrek	Sterility	Nationwide

More recalls from Iantrek

All 2

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS II	The C-Rex UNO Microinterventional Goniotomy Instrument recalled	Iantrek	Sterility	Nationwide

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