CLASS II Device recall · Reported 5 Jun 2019 · FDA Enforcement Report
ThermaCare Heatwraps, Advanced Back Pain Therapy recalled
PF Consumer Healthcare 1 is recalling ThermaCare Heatwraps, Advanced Back Pain Therapy, distributed nationwide in the US. The recall was initiated on 26 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1495-2019
- FDA event ID
- 82781
- Recalling firm
- PF Consumer Healthcare 1, Albany, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2019
- FDA classified
- 28 May 2019
- Reported
- 5 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 26 Apr 2019 | Recall initiated by company | |
| 28 May 2019 | Classified by FDA | +32 days |
| 5 Jun 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Number S97473
Where was it sold?
Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82781| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ThermaCare Heatwraps, Advanced Back Pain Therapy recalled | PF Consumer Healthcare 1 | Temperature Abuse | Nationwide |
More recalls from PF Consumer Healthcare 1
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ThermaCare Heatwraps, Advanced Back Pain Therapy recalled | PF Consumer Healthcare 1 | Temperature Abuse | Nationwide |
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