Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 2, 2016
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
"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 invest…
Bigwall Enterprises recalled WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch… — a moderate-severity action.
WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch… was recalled by Bigwall Enterprises in March 2, 2016. Reason: "The public reason for the recall is that the product is being recalled out of an abundance of caution due to…. Check the official notice for the remedy. Verify recall #Z-0698-2016 with the FDA Devices before acting.
The recall
Bigwall Enterprises issued this moderate-severity FDA Devices recall — "The public reason for the recall is that the product is being recalled out of an abundance of caution due to….
- Moderate
- severity level
- 88K units
- affected scope
- Class II
- classification
- March 2, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0698-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0698-2016) was formally reported on March 2, 2016, with the manufacturer initiating the action on November 20, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Bigwall Enterprises is listed as the recalling firm, operating out of Clarendon Hills, IL. Federal records list the affected scope as 87503.
The documented reason for this recall is: "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 causa… Distribution data in the federal record shows the product reached: Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
87503
Related Recalls
6
6 from same agency
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
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."
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0698-2016 |
| Date reported | March 2, 2016 |
| Date initiated | November 20, 2015 |
| Recalling firm | Bigwall Enterprises |
| Firm location | Clarendon Hills, IL |
| Affected scope | 87503 |
| Distribution | Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0698-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bigwall Enterprises. Units affected: 87503.
Why was this product recalled? ▼
"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."
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0698-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including Washington, DC, U.S. Virgin Islands, and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0698-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 2, 2016.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.