The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0556-2019·Announced 2018-12-12

Pfizer Recalls Thermacare Heatwraps Due to Material Leakage

Pfizer is recalling specific lots of Thermacare Heatwraps because the wraps may come apart and leak granular material.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves physical leakage of granular material without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Pfizer Inc. is recalling specific lots of Thermacare HEATWRAPS JOINT PAIN THERAPY and MUSCLE PAIN THERAPY. The recall involves 4,956 units distributed nationwide and in Puerto Rico. The affected products are identified by UPC 0573301311 and specific bundled lot numbers 8054HA and 8054HB.

The recall was initiated after the firm received complaints that the wraps came apart and leaked granular material. These products are used to provide heat therapy for temporary relief of minor muscular and joint aches and pains.

Consumers with these specific products should stop using them and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and…
Manufacturer
Pfizer Inc.
Category
Medical Device — Thermal Therapy
Hazard
Affected units
4,956

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Pfizer Inc. 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 3 products in this recall →

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