Reported Aug 4, 2021 · Ongoing

OxyMask O2 Adult REF OM-1125-14

Southmedic, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Southmedic, Inc. · 50 Alliance Blvd · Barrie, N/A · N/A

Is this the product you have?

  • OxyMask O2 Adult REF OM-1125-14
Lot codes and dates
  • ModelOM-1125-14
  • Lot NumberW73887
Amount recalled
160 cases (25 units per case) in U.S.

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.