WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow… — Class II medical device recall Z-0698-2016
Terminated recall by Bigwall Enterprises, reported 2016-03-02, distributed nationwide. "The public reason for the recall is that the product is being recalled out of an abundance of caution due to
| Recall number | Z-0698-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bigwall Enterprises, Clarendon Hills, IL, United States |
| Recall initiated | 2015-11-20 |
| Classified | 2016-02-24 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2018-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 87,503 |
| Lot numbers | 01/15, 03/15, 08/14, 12/14, 14220PCS, 20040PCS, 21096PCS, 45228PCS |
| Model numbers | 366596, PJ1011 |
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 allergies
Reason for recall
"The public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investigated and remain unconfirmed. No causal connection between the complaints and the producta¿"s proper use as instructed have been determined."
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0698-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.