Reported Nov 6, 2019 · Terminated

POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows

POM Medical LLC

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: POM Medical LLC · 11959 Discovery Ct · Moorpark, CA · 93021-7120

Is this the product you have?

4 of 4 products

Products covered by this recall
Model / numberProduct as published
1001-MMLot numbers 021418-021421, 032218-032221, 032618-032621, and 032818-032821
KE1001-MMan internal number used by one of the distributors (same as 1001-MM) - Lot numbers 021418-021421 and 032818-032821
301-0318LTLot numbers 022218-022221, 032218-032221, 032618-032621
1001-MFand - Lot number 032818-032821.
Amount recalled
5,610 units

Where it was sold

Why it was recalled

Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port.

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

Notice updated Jan 4, 2021 · Data as of Sep 19, 5:22 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.