Z-1197-2008

Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2...

Name: Z-1197-2008 Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2...
Creator: Chattem Inc
Published: 2008-02-12
License: https://open.fda.gov/license/

Chattem, Inc. / initiated 2008-02-12 / Terminated / root cause: design

FDA source

Chattem Inc began a recall of Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5 cm)... on 2008-02-12. The reason FDA records is "Skin irritation and burns with product usage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1197-2008
Status: Terminated
Initiated: 2008-02-12
Posted: 2008-03-08
Terminated: 2009-10-05
Recalling firm: Chattem, Inc.
Product: Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5 cm) each, 1 and 4 count patches, Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219
Product code: IMD Pack, Hot Or Cold, Disposable
Reason for recall: Skin irritation and burns with product usage
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 666,636 units (total for Recalls Z-1196-1197-2008)
Distribution: Worldwide - USA, Canada, and Honduras
Product codes and lots: All Lots

Product code IMD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)