Vyaire Medical recalls pediatric AirLife resuscitation devices with potential airflow obstruction during oxygen delivery. Affected models include specific part numbers and lot numbers. Consumers should contact Vyaire for details.
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
Vyaire Medical is recalling pediatric AirLife resuscitation devices that may obstruct oxygen flow during use. This could be dangerous for infants or children needing emergency breathing support.
A manufacturing error in the device could block oxygen flow during use, which is critical for infants or children who need emergency breathing assistance. This obstruction could lead to inadequate oxygen delivery and potential harm.
Parents, caregivers, and healthcare providers who use pediatric AirLife resuscitation devices for emergency breathing support. Infants and children are most at risk due to their small airways.
Check for part numbers: 2K8018, 2K8008, RE1DK5445D, or 2K8039. Look for specific lot numbers listed in the recall notice. These devices are used for pediatric emergency resuscitation.
Identify the part number and lot number on your device to confirm if it is affected.
Reach out to Vyaire Medical for instructions on how to return or replace the device.
An error in manufacturing could obstruct oxygen flow during use, which is critical for infants or children needing emergency breathing support.
Pediatric AirLife resuscitation devices with part numbers 2K8018, 2K8008, RE1DK5445D, or 2K8039 and specific lot numbers.
No, but you should check the part number and lot number to confirm if it is affected. Contact Vyaire for further instructions.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2553-2018 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-2553-2018 from Vyaire 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.
