PF Consumer Healthcare 1 LLC: Medical Device Recall in 2019 - (Recall #: Z-1495-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 26, 2019

Date Posted: June 5, 2019

Recall Number: Z-1495-2019

Event ID: 82781

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.

Status: Terminated

Product Quantity: 155,904 individual HeatWraps

Code Information:

Lot Number S97473

Distribution Pattern:

Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated