Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
AirLife Resuscitation Device Recalled by Vyaire Medical Due to An error in manufacturing of the AirLife Resuscitation...
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 Vyaire Medical directly.
Affected Products
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen reservoir tubing, Part Number 2K8005; e. Adult, with mask, 40" oxygen reservoir tubing, PEEP valve, Part Number 2K8036; f. Adult, without mask, 40" oxygen reservoir tubing, Part Number 2K8001; g. Adult, with mask, oxygen reservoir bag, manometer, PEEP valve, Part Number 2K8035M; h. Adult, with mask, oxygen reservoir bag, CO2 detector, Part Number 2K8004C2; Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.
Quantity: 15,714 units total
Why Was This Recalled?
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
Where Was This Sold?
This product was distributed to 27 states: AL, AZ, AR, CA, CO, FL, GA, HI, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OR, SD, TX, VA, WA
About Vyaire Medical
Vyaire Medical has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report