FDA Medical Device Recalls (openFDA)
Bigwall Enterprises: 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
- Recall number
- Z-0698-2016
- 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
- Status
- Terminated
- Initiated
- 2015-11-20
- Posted
- not on file
- Terminated
- 2018-03-06
- Reason
- "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."
- 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
- 87503
- Distribution
- Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KFZ
- Firm FEI
- 3008651658
- Firm city
- Clarendon Hills
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28