ThermaCare HEATWRAPS — Class II medical device recall Z-1496-2019
Terminated recall by PF Consumer Healthcare 1 LLC, reported 2019-06-05, distributed nationwide. There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified
| Recall number | Z-1496-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PF Consumer Healthcare 1 LLC, Albany, GA, United States |
| Recall initiated | 2019-04-26 |
| Classified | 2019-05-28 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2024-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, GB, IE, MT, NL |
| Quantity | 225,617 individual |
Product
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B 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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1496-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.