Safety recall
Medical
FDA
Is the Respironics SealFlex Single Port Ribbed Mask (Infant).… safe?
Engineered Medical Systems,Inc · Recalled Sep 12, 2011
No — the Respironics SealFlex Single Port Ribbed Mask (Infant).… was recalled on Sep 12, 2011 due to a safety issue. The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. If you have this product: Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Why it was recalled
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
What to do
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.
Respironics SealFlex Single Port Ribbed Mask (Infant).…: common questions
Is the Respironics SealFlex Single Port Ribbed Mask (Infant).… safe?
No. The Respironics SealFlex Single Port Ribbed Mask (Infant).… was recalled on Sep 12, 2011 due to a safety issue. The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Has the Respironics SealFlex Single Port Ribbed Mask (Infant).… been recalled?
Yes. The Respironics SealFlex Single Port Ribbed Mask (Infant).… was recalled on Sep 12, 2011. The recall was issued by FDA (recall ID Z-1058-2013).
Why was the Respironics SealFlex Single Port Ribbed Mask (Infant).… recalled?
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
What should I do if I have the Respironics SealFlex Single Port Ribbed Mask (Infant).…?
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Where can I find the official recall notice for the Respironics SealFlex Single Port Ribbed Mask (Infant).…?
The official FDA recall record is available
here. Always verify recall details with the official source.
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