# FDA recall Z-1288-2018

> **Southmedic, Inc.** · Class II · device recall initiated 2017-10-17.

## Product

Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case.    Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.

## Reason for recall

Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

## Distribution

US Distribution to the state of  California, and Internationally to Canada and Sweden

## Key facts

- **Recall number:** Z-1288-2018
- **Recalling firm:** Southmedic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-17
- **Report date:** 2018-04-11
- **Termination date:** 2024-03-29

- **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-1288-2018

## Citation

> AI Analytics. FDA recall Z-1288-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1288-2018. Source: US FDA. Licensed CC0.

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