Recall of Device Recall Icy Hot Heat Therapy

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Chattem 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
    Air Activated Heat Patch - Product Code IMD
  • Reason
    Skin irritation and burns with product usage.
  • Action
    The firm initiated its recall on 02/08/2008 by issuing a press release warning the public of the hazard and directing them to stop its use and either return or discard the products. The firm initiated the recall at the retail level on 02/12/2008 by notifying its employee sales force by email, containing a Urgent Medical Device Recall Letter, with instructions to immediately email a copy of the recall letter to each Chattem consignee (wholesalers and direct retail accounts) with sub recall requests.


  • Model / Serial
    Only those Aspercreme units that have the "bonus packs" containing any lot of the Icy Hot Heat Therapy patches.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide - USA, Canada, and Honduras
  • Product Description
    Aspercreme, Pain Relieving Creme with Aloe, Maximum Strength Formula, Net Wt 3oz (85g) with Bonus Icy Hot Heat Therapy Air Activated Heat Patch, 1 individually wrapped patch, 3.9" x 5.3" (10cm x 13.5cm), Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219
  • Manufacturer


  • Manufacturer Address
    Chattem Inc, 1715 W 38th St, Chattanooga TN 37409-1248
  • Manufacturer Parent Company (2017)
  • Source