Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 17, 2024
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential he…
SoClean, Inc recalled SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System. - a moderate-severity action.
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System. was recalled by SoClean, Inc in January 17, 2024. Reason: New User Manual with additional instructions for use and a hose and mask adapter provided by the device manuf…. Check the official notice for the remedy. Verify recall #Z-0695-2024 with the FDA Devices before acting.
The recall
SoClean, Inc issued this moderate-severity FDA Devices recall-New User Manual with additional instructions for use and a hose and mask adapter provided by the device manuf….
- Moderate
- severity level
- 2.3M units
- affected scope
- Class II
- classification
- January 17, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0695-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0695-2024) was formally reported on January 17, 2024, with the manufacturer initiating the action on November 15, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. SoClean, Inc is listed as the recalling firm, operating out of Peterborough, NH. Federal records list the affected scope as 2,339,352, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas afte… Distribution data in the federal record shows the product reached: Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Egypt, El Salvador, England, France, Germany, Hong Kong, Isle of Man, Israel, Italy…. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
2,339,352
Related Recalls
6
3 from same agency
Product description
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Reason for recall
New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0695-2024 |
| Date reported | January 17, 2024 |
| Date initiated | November 15, 2023 |
| Recalling firm | SoClean, Inc |
| Firm location | Peterborough, NH |
| Affected scope | 2,339,352 |
| Distribution | Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Egypt, El Salvador, England, France, Germany, Hong Kong, Isle of Man, Israel, Italy, Japan, Jordan, Kor… |
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-0695-2024) 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? ▼
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.. Recalled by SoClean, Inc. Units affected: 2,339,352.
Why was this product recalled? ▼
New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0695-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Egypt, El Salvador, England, France, Germany, Hong Kong, Isle of Man, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, New Zealand, Portugal, Russia, Saudi Arabia, Seoul, Singapore, Spain, Sri Lanka, Switzerland, Thailand, Netherlands, Turkey, United Arab Emirates, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0695-2024) 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.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 17, 2024. 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 July 2026.