Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 5, 2019
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
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 …
Pf Consumer Healthcare 1 LLC recalled ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: Therm… - a moderate-severity action.
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: Therm… was recalled by Pf Consumer Healthcare 1 LLC in June 5, 2019. Reason: There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified…. Check the official notice for the remedy. Verify recall #Z-1495-2019 with the FDA Devices before acting.
The recall
Pf Consumer Healthcare 1 LLC issued this moderate-severity FDA Devices recall-There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified….
- Moderate
- severity level
- Class II
- classification
- June 5, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1495-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1495-2019) was formally reported on June 5, 2019, with the manufacturer initiating the action on April 26, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Pf Consumer Healthcare 1 LLC is listed as the recalling firm, operating out of Albany, GA. Federal records list the affected scope as 155,904 individual HeatWraps.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
155,904 individual HeatWraps
Related Recalls
6
6 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1495-2019 |
| Date reported | June 5, 2019 |
| Date initiated | April 26, 2019 |
| Recalling firm | Pf Consumer Healthcare 1 LLC |
| Firm location | Albany, GA |
| Affected scope | 155,904 individual HeatWraps |
| Distribution | Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1495-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pf Consumer Healthcare 1 LLC. Units affected: 155,904 individual HeatWraps.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2019. Severity: Moderate. Recall number: Z-1495-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and PR, and countries of Ireland, UK, Malta, Netherlands, Germany, and Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1495-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 5, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.