Source: FDA device Enforcement Reports Z-0695-2024 / Z-0694-2024 · Safety Comm Nov 21, 2023 · Updated
Is my SoClean 2 or SoClean 3 recalled?
Yes — if you have a SoClean 2 (REF SC1200) or SoClean 3 (REF SC1400). FDA lists both under Class II recall event 93570, with status Ongoing as of the October 26, 2026 check. The field correction is a new User Manual plus a hose and mask adapter to reduce the risk of ozone gas exposure. Do not use SoClean 2 or 3 without the adapter. Never connect SoClean while the CPAP is in use. Follow your CPAP maker’s cleaning instructions and call SoClean Customer Care at 866-501-3705 for a no-cost adapter. This is not the Philips Respironics CPAP foam recall.
Last updated: · Sources: two openFDA device Enforcement Reports and FDA’s November 21, 2023 Safety Communication, including its August 2024 update.
- Scope
- 2 models
- Class
- Class II
- Event
- 93570
- Status
- Ongoing (checked Oct 26, 2026)
- Remedy
- Adapter + new manual
- Recall topic
- SoClean ozone cleaner; separate from Philips foam
Recalled models ↓ · Get the adapter ↓ · Refund information ↓
Recalled SoClean models at a glance
Match the model and REF on your device or packaging, then compare the product code in the same row.
| Recall # | Model | REF | Code (UPC / UDI) | Qty (FDA) | Class / status |
|---|---|---|---|---|---|
| Z-0695-2024 | SoClean 2 | SC1200 | UPC 187293000860 | 2,339,352 | Class II · Ongoing |
| Z-0694-2024 | SoClean 3 | SC1400 | UDI (01)00858242007147 | 40,075 | Class II · Ongoing |
Both records are in event 93570. SoClean, Inc. initiated the voluntary recall on November 15, 2023; FDA classified it on January 10, 2024 and reported it on January 17, 2024. The quantities above are the amounts FDA lists in commerce, not counts of injuries or adapter requests.
Product codes follow openFDA. FDA’s Safety Communication prints “UCP” for SoClean 2; openFDA labels it “UPC.” For help locating codes, see finding codes on a device or package.
What was the problem? (ozone / adapter)
FDA’s recall reason describes revised User Manuals with additional instructions and a manufacturer-supplied hose and mask adapter to help reduce potential health risks from ozone exposure after SoClean use.
The Safety Communication explains that the adapter goes between the SoClean ozone tubing and the ventilation hose to keep ozone from entering the CPAP machine or its water reservoir. The revised manual also gives instructions for allowing ozone left in the mask or tubing after cleaning to dissipate. Follow the updated manual’s setup and use instructions.
How to get the hose and mask adapter
- Do not use SoClean 2 or SoClean 3 without the manufacturer’s hose and mask adapter.
- Call SoClean Customer Care at 866-501-3705 to obtain a no-cost adapter and the updated User Manual for your model.
- Read and follow the revised manual. Never connect SoClean to your CPAP when the CPAP is in use.
- Continue to follow your CPAP manufacturer’s cleaning instructions, including restrictions on ozone use. SoClean’s instructions supplement those procedures.
The recall notice historically directed users to soclean.com/field-correction. On October 26, 2026, that address redirected to SoClean 3+ support rather than the original field-correction form. Call the number above for help with the SoClean 2 or 3 recall.
General guidance: what to do with a recalled product.
Is there a SoClean recall refund?
No primary FDA or SoClean US recall-refund program was verified as of October 26, 2026. The documented remedy is a free hose and mask adapter plus updated manuals. No verified refund amount, settlement payment, claim portal or deadline is available to list. Ask SoClean about the documented correction at 866-501-3705.
SoClean vs Philips CPAP foam recall
These are separate recalls. SoClean 2 and 3 are cleaner accessories; this correction addresses ozone exposure. The Philips Respironics recall concerns deteriorating sound-abatement foam in certain CPAP and BiPAP machines. A SoClean adapter does not resolve a Philips machine’s foam recall.
SoClean 3+ — different product
SoClean 3+ is not the SoClean 2 or SoClean 3 in these recall records. FDA’s August 2024 update says it authorized SoClean 3+ for marketing as an add-on after regular cleaning to reduce bacteria on certain CPAP masks and ventilation hoses. FDA explicitly says its recommendations for SoClean 2 and 3 have not changed. The separate authorization does not close these two recall records or replace their adapter and manual instructions.
Who should be careful with ozone?
FDA’s Safety Communication says people with underlying lung disease, including asthma or COPD, and those with cardiovascular disease may be sensitive to ozone. Consult your health care provider before using a SoClean device if this applies to you. Follow the CPAP manufacturer’s cleaning instructions.
Search FDA recalls, including medical devices.
Official sources
- openFDA device Enforcement Report Z-0695-2024: SoClean 2, product codes, quantity, dates, class and status — Checked: October 26, 2026
- openFDA device Enforcement Report Z-0694-2024: SoClean 3, product codes, quantity, dates, class and status — Checked: October 26, 2026
- FDA Safety Communication (Nov. 21, 2023; updated Aug. 2024): adapter instructions, ozone precautions and separate SoClean 3+ authorization — Checked: October 26, 2026
- FDA Class 2 Device Recall: SoClean 2 (event 93570; action and customer contact) — Checked: October 26, 2026
- FDA Class 2 Device Recall: SoClean 3 (event 93570; action and customer contact) — Checked: October 26, 2026
FAQ
Is SoClean recalled?
Yes. FDA lists Class II recalls Z-0695-2024 for SoClean 2 and Z-0694-2024 for SoClean 3 under event 93570. Both records were Ongoing when checked on October 26, 2026.
Which models / codes?
SoClean 2 REF SC1200 and SoClean 3 REF SC1400. Compare the UPC or UDI on your device or packaging with the model table above. SoClean 3+ is a separate product and is not included in these two recall records.
Do I need an adapter?
Yes. FDA says not to use SoClean 2 or SoClean 3 without the manufacturer’s hose and mask adapter. Read and follow the updated User Manual.
How do I get a free adapter?
Call SoClean Customer Care at 866-501-3705 to obtain a no-cost hose and mask adapter. The historic soclean.com/field-correction address redirected to SoClean 3+ support when checked on October 26, 2026, so use the phone number for help with the recall.
Is there a refund?
No primary FDA or SoClean US recall-refund program was verified as of October 26, 2026. The documented correction is a free hose and mask adapter and updated manuals. We have no verified recall-refund amount or claim deadline to list.
Is this the Philips CPAP recall?
No. The Philips Respironics foam recall concerns certain CPAP and BiPAP machines and their sound-abatement foam. The SoClean recall concerns a separate cleaner accessory and ozone exposure.
How many units?
FDA lists 2,339,352 SoClean 2 units and 40,075 SoClean 3 units in commerce in these two recall records.
Can I keep using it?
FDA says not to use SoClean 2 or SoClean 3 without the adapter and to follow the updated manuals. Never connect SoClean to a CPAP while the CPAP is in use. Follow your CPAP manufacturer’s cleaning instructions. If you have lung or cardiovascular disease, consult your health care provider before using SoClean.
Update log
- Oct 26, 2026 — Published from FDA device Enforcement Reports Z-0695-2024 and Z-0694-2024 and the FDA Safety Communication. Noted the field-correction URL redirect; no primary US recall-refund program verified.