Recall of Device Recall Sage InVitro Fertilization

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CooperSurgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Media, reproductive - Product Code MQL
  • Reason
    Products contain international package insert and not the correct usa package insert.
  • Action
    CooperSurgical sent an Advisory Notice dated August 25, 2016, to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. The advisory notification asked customers to replace the previously inserted incorrect Instructions for use (IFU) with the correct IFU sent with the advisory notification. For questions regarding this recall call 203-601-5200.


  • Model / Serial
    Lot No. 15420123 Expires Oct. 2016
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution to CA, GA, and NY
  • Product Description
    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 || SAGE In Vitro Fertilization, Inc. || A CooperSurgical Company || 95 Corporate Drive || Trumbull, CT 06611 USA
  • Manufacturer


  • Manufacturer Address
    CooperSurgical, Inc., 95 Corporate Dr, Trumbull CT 06611-1350
  • Manufacturer Parent Company (2017)
  • Source