According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Microtek Medical 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 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
    Gown, surgical - Product Code FYA
  • Reason
    This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 cfr 801.437; it does not contain caution: the packaging of this product contains natural rubber latex which may cause allergic reactions.
  • Action
    The firm, Ecolab - Microtek Medical, sent an "Urgent: Recall - Mislabeled Product Immediate Action Required" letter dated March 2015 to its US customers on 03/10/2015 via letter and email. The letter describes product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and promptly quarantine the lot(s) listed; complete and return the enclosed Recall Response Form via fax to Quality Assurance Manager, Ecolab-Microtek Medical at (662) 244-3011 or email to: RE: Recall - Mislabeled Product ASAP, and if you have further distributed the products subject to this recall, please notify your customers at once. Upon receipt of the completed response forms, Ecolab-Microtek Medical will issue a return material authorization (RMA) and ask that you return any unopened product listed above to Ecolab-Microtek Medical at the address listed in the attached form. If you have any questions in regard to this recall, please contact Customer Service by phone at 1-800-824-3027 or email;


  • Model / Serial
    Lot Numbers: C9257, C9324, C10025, C10043, C10067, C10165, C10230, C10237, C11321, C11325, C12251, C13063, C13325
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US (nationwide) Distribution.
  • Product Description
    FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX || The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
  • Manufacturer


  • Manufacturer Address
    Microtek Medical Inc, 602 N Lehmberg Rd, Columbus MS 39702-4406
  • Manufacturer Parent Company (2017)
  • Source