# FDA recall Z-2141-2021

> **Southmedic, Inc.** · Class II · device recall initiated 2021-05-25.

## Product

OxyMask O2 Adult REF OM-1125-14

## 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.

## Distribution

U.S.: IL    O.U.S.: N/A

## Key facts

- **Recall number:** Z-2141-2021
- **Recalling firm:** Southmedic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-25
- **Report date:** 2021-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Barrie, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2141-2021

## Citation

> AI Analytics. FDA recall Z-2141-2021. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-2141-2021. Source: US FDA. Licensed CC0.

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