The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1496-2019·Announced 2019-06-05

ThermaCare HeatWraps Recalled for Potential Skin Burn Risk

PF Consumer Healthcare 1 LLC 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 physical injury (burns/blisters) from a medical device, but the source text does not report any actual injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

PF Consumer Healthcare 1 LLC is recalling ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY. The recall involves specific SKUs (F00573301020A, F00573301026X, F00573301009B) and lot numbers (S23902, W37940, S00639). The affected products were distributed worldwide, including the United States, Puerto Rico, Ireland, the UK, Malta, the Netherlands, Germany, and Switzerland.

The recall was initiated because there is a potential that heat cells in the wraps may reach temperatures higher than specified. Using 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.

Consumers who have purchased these specific products should stop using them immediately. The source text does not provide specific instructions for disposal or return, but users should avoid applying the affected wraps to their skin to prevent potential injury.

The recalled product

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…
Manufacturer
PF Consumer Healthcare 1 LLC
Category
Medical Device — Thermal Therapy
Hazard
Affected units
225,617

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 Numbers: a) S23902 b) W37940 c) S00639

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 →

Related recalls

Same manufacturer · PF Consumer Healthcare 1 LLC

See all →

Same hazard · burn injury

See all →

Similar recalls