Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Recalled by CooperSurgical, Inc. Due to Products contain international package insert and not the...

Date: August 25, 2016
Company: CooperSurgical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CooperSurgical, Inc. directly.

Affected Products

Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).

Quantity: 4 units

Why Was This Recalled?

Products contain international package insert and not the correct USA package insert

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CooperSurgical, Inc.

CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report