Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use Recalled by Engineered Medical Systems,Inc Due to The mask inside the package has been identified...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Engineered Medical Systems,Inc directly.
Affected Products
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
Quantity: 1500pcs, 75cs {20pcs per cases)
Why Was This Recalled?
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Where Was This Sold?
This product was distributed to 5 states: CA, CO, IN, NY, PA
About Engineered Medical Systems,Inc
Engineered Medical Systems,Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report