The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1495-2019·Announced 2019-06-05

ThermaCare HeatWraps Recalled for Potential Skin Burn Risk

PF Consumer Healthcare is recalling ThermaCare HeatWraps because some units may produce higher-than-specified temperatures, posing a risk of skin burns or blisters.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (burns/blisters) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed cases.

Plain-English summary

PF Consumer Healthcare 1 LLC is recalling 155,904 units of ThermaCare HeatWraps, Advanced Back Pain Therapy (UPC 305733010037, Lot Number S97473). The recall was initiated because there is a potential that some heat cells in this specific lot may reach temperatures higher than specified.

The use of heat wraps with increased temperatures poses a potential risk of skin injuries, including burns, blisters, and skin irritation on the area where the wrap is applied. The affected products were distributed worldwide, including in the United States, Puerto Rico, Ireland, the UK, Malta, the Netherlands, Germany, and Switzerland.

Consumers who have purchased this specific lot of ThermaCare HeatWraps should stop using the product immediately. The source text does not provide specific instructions for disposal or refund, but users should avoid applying the wrap to their skin to prevent potential injury.

The recalled product

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…
Manufacturer
PF Consumer Healthcare 1 LLC
Category
Medical Device — Thermal Therapy
Hazard
Affected units
155,904

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number S97473

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by PF Consumer Healthcare 1 LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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