Bigwall Enterprises: Medical Device Recall in 2016 - (Recall #: Z-0698-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 20, 2015

Date Posted: March 2, 2016

Recall Number: Z-0698-2016

Event ID: 72837

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."

Status: Terminated

Product Quantity: 87503

Code Information:

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

Distribution Pattern:

Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated