FDA Device recall Z-2141-2021
OxyMask O2 Adult REF OM-1125-14
- FDA Device
- Class II
- ongoing
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of OxyMask O2 Adult REF OM-1125-14 by Southmedic, citing 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 la….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2141-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-25 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Southmedic |
| Distribution | IL |
Product
OxyMask O2 Adult REF OM-1125-14
Reason
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.
Identifiers
| code_info | Model: OM-1125-14 Lot Number: W73887 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2141-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.