POM Medical recalls endoscopic oxygen masks with re-breather bag inflation issues or oxygen line disconnections. Affected models include 1001-MM and 1001-MF with specific lot numbers.
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.
POM Medical is recalling endoscopic oxygen masks that may not inflate properly or cause oxygen lines to pop off. This could lead to oxygen delivery failure during medical procedures.
The re-breather bag may not fill or inflate, causing oxygen delivery to stop. The oxygen line can pop off after oxygen is turned on due to a clogged port, potentially interrupting oxygen flow during critical medical procedures.
Healthcare providers using these masks during procedures like bronchoscopy or conscious sedation are most at risk. Patients receiving oxygen through these masks could be affected if the mask malfunctions.
Check for model numbers 1001-MM, 1001-MF, or 301-0318LT with specific lot numbers listed in the recall notice. These masks were distributed by POM Medical or Sarnova HC.
Identify the model number (1001-MM, 1001-MF, or 301-0318LT) and lot number from the packaging.
The recall is due to complaints that the re-breather bag may not inflate or the oxygen line can pop off after oxygen is turned on.
Affected models include 1001-MM (lots 021418-021421, 032218-032221, 032618-032621, 032818-032821), 1001-MF (lot 032818-032821), and 301-0318LT (lots 022218-022221, 032218-032221, 032618-032621).
The recall does not require immediate stop use; however, healthcare providers should check model and lot numbers to ensure they are not affected.
We’ve drafted a message you can send POM Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0262-2020 — POM Medical POM Medical Hello, I own a POM Medical that is covered by recall Z-0262-2020 from POM Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.