Pfizer Recalls Thermacare HeatWraps Due to Leaking Granular Material
Pfizer is recalling Thermacare Muscle Pain Therapy 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 a product defect (leaking material) without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Pfizer Inc. is recalling Thermacare Muscle Pain Therapy HeatWraps, a medical device used to provide heat therapy for temporary relief of minor muscular and joint aches and pains. The recall involves 119,232 units distributed nationwide in the US and Puerto Rico.
The recall was initiated after the firm received complaints that the wraps were coming apart and leaking granular material. The affected products are identified by UPC 0573301314 (Lot Number S68516) and UPC 0573301303 (Lot Number T26686).
Consumers should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.
- Manufacturer
- Pfizer Inc.
- Category
- Medical Device — Thermal Therapy
- Affected units
- 119,232
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.
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