Recall of 7x10" Small Utility Positioner with Cover

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Molnlycke Health Care, 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 2
  • Event Number
  • Event Initiated Date
  • Event Status
    Open, Classified
  • Event Country
  • 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
    Infant Positioner, Rx, Use In Highly Monitored Setting - Product Code OUW
  • Reason
    Products may not meet specifications due to possible presence of metal shavings.
  • Action
    Customers were notified by letter via overnight mail on approximately 07/26/2017. Instructions include identify and quarantine affected product in inventory, contact Molnlycke to arrange return of affected product, and complete and return the Acknowledgement Form.


  • Model / Serial
    Recorder Code 1400227
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
  • Product Description
    7x10" Small Utility Positioner with Cover
  • Manufacturer


  • Manufacturer Address
    Molnlycke Health Care, Inc, 5550 Peachtree Pkwy Ste 500, Norcross GA 30092-2555
  • Manufacturer Parent Company (2017)
  • Source