Bigwall WARM STEAM Personal Steam Inhaler Recalled for Unconfirmed Consumer Complaints
Bigwall Enterprises is recalling WARM STEAM Personal Steam Inhalers nationwide due to unconfirmed consumer complaints. No causal link to product use has been established.
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 a voluntary precautionary measure based on unconfirmed complaints with no established causal connection to product use, fitting the criteria for a moderate severity score.
Plain-English summary
Bigwall Enterprises is voluntarily recalling the WARM STEAM Personal Steam Inhaler, model PJ1011, in response to consumer complaints. The product is sold under the 'Well at Walgreens' brand and is intended to help relieve symptoms of stuffy nasal passages, congestion, or scratchy throats. The recall covers approximately 87,503 units distributed nationwide, including Washington, DC, the U.S. Virgin Islands, and Puerto Rico.
The recall is being conducted out of an abundance of caution. The complaints have been independently investigated and remain unconfirmed. The source text explicitly states that no causal connection between the complaints and the product's proper use as instructed has been determined.
Consumers who have purchased this product should stop using it and contact Bigwall Enterprises for further instructions. The affected lots include 08/14, 12/14, 01/15, and 03/15.
The recalled product
- Product
- WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or…
- Manufacturer
- Bigwall Enterprises
- Hazard
- Affected units
- 87,503
Distribution
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