CLASS II ONGOING Device recall · Reported 4 Aug 2021 · FDA Enforcement Report
OxyMask O2 Adult recalled by Southmedic
Southmedic is recalling OxyMask O2 Adult, distributed in Illinois. The recall was initiated on 25 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2141-2021
- FDA event ID
- 88103
- Recalling firm
- Southmedic, Barrie, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 May 2021
- FDA classified
- 23 Jul 2021
- Reported
- 4 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 25 May 2021 | Recall initiated by company | |
| 23 Jul 2021 | Classified by FDA | +59 days |
| 4 Aug 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
Product as listed by the FDA
OxyMask O2 Adult REF OM-1125-14
Where it was distributed
U.S.: IL O.U.S.: N/A
Questions about this recall
Why was it recalled?
Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
Which lots are affected?
Model: OM-1125-14 Lot Number: W73887
Where was it sold?
U.S.: IL O.U.S.: N/A
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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