Pfizer Recalls Thermacare HeatWraps Menstrual Due to Material Leakage
Pfizer is recalling Thermacare HeatWraps Menstrual 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 FDA classified this as a Class II recall. The hazard involves physical integrity failure (leaking granular material) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pfizer Inc. is recalling Thermacare HeatWraps Menstrual, a medical device used to provide heat therapy for temporary relief of minor menstrual cramp pain and associated back aches. The recall affects approximately 293,880 units distributed nationwide in the United States 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 0573302002 (Carton/Pouch Number T26691) and UPC 0573302044 (Carton/Pouch Number T26693).
Consumers should stop using the recalled products and check their packaging for the specific UPC and carton/pouch numbers listed above. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.
- Manufacturer
- Pfizer Inc.
- Category
- Medical Device — Thermal Therapy
- Affected units
- 293,880
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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