Z-0698-2016Class II

WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal...

Name: Z-0698-2016 WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal...
Creator: Bigwall Enterprises
Published: 2015-11-20
License: https://open.fda.gov/license/

Bigwall Enterprises / initiated 2015-11-20 / Terminated

FDA source

Bigwall Enterprises began a recall of WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at... on 2015-11-20. FDA classified it as Class II and gives the reason as ""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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0698-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Posted: 2016-02-25
Terminated: 2018-03-06
Recalling firm: Bigwall Enterprises
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
Product code: KFZ Humidifier, Non-Direct Patient Interface (Home-Use)
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."
FDA root cause: Unknown/Undetermined by firm
Action: The firm has only sold the product to Walgreens. Walgreens has notified all of its distribution centers and stores. According to the firm: "Walgreens has issued a stop sale at the store level. Units removed from store shelves and in stock will be sent back to the Walgreens distribution center Valparaiso, Indiana. As units are received from all store locations they will be sent to Bigwall Enterprises."
Quantity in commerce: 87503
Distribution: Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico.
Product codes and lots: Model: PJ1011 Item: 366596 UPC code: 31191717008 Lot No. 08/14: 45228pcs Lot No. 12/14: 21096pcs Lot No. 01/15: 14220pcs Lot No. 03/15: 20040pcs

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0698-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0698-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24

Product code KFZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)