Z-1495-2019Class II

ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 -

Name: Z-1495-2019 ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 -
Creator: PF Consumer Healthcare 1 LLC
Published: 2019-04-26
License: https://open.fda.gov/license/

Angelini Pharma Inc. / initiated 2019-04-26 / Terminated

FDA source

PF Consumer Healthcare 1 LLC began a recall of ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for... on 2019-04-26. FDA classified it as Class II and gives the reason as "There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with increased temperatures poses a potential risk of skin injuries...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1495-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-26
Posted: 2019-05-28
Terminated: 2024-06-11
Recalling firm: Angelini Pharma Inc.
Product: ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.
Product code: IMD Pack, Hot Or Cold, Disposable
Reason for recall: There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with increased temperatures poses a potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap-applied area.
FDA root cause: Other
Action: The firm initiated the recall by press release on 04/26/2019. Notification packages to direct consignees were sent on 04/29/2019. The consignees were directed to cease distribution and return the product. Distributors were directed to sub-recall. Retailers were asked to post the press release either at the cash register or another prominent location.
Quantity in commerce: 155,904 individual HeatWraps
Distribution: Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland.
Product codes and lots: Lot Number S97473

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1495-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1495-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-28
Z-1496-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-28

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)