ThermaCare Heatwraps (PF Healthcare) – Cell Temperature Risk (2019)
Higher cell temperatures can potentially cause skin burns or irritation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, a
Brand
PF Consumer Healthcare 1 LLC
Lot Codes / Batch Numbers
Lot Number S97473
Products Sold
Lot Number S97473
PF Consumer Healthcare 1 LLC is recalling ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) He due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026