Vyaire Medical AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
Brand
Vyaire Medical
Lot Codes / Batch Numbers
UDI/DI Case: 50190752114089, Each: 10190752114081, All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
Products Sold
UDI/DI Case: 50190752114089, Each: 10190752114081; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
Vyaire Medical is recalling AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000, due to Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Recommended Action
Per FDA guidance
Vyaire issued an URGENT: Customer notification Letter to its consignees on 01/10/2024 via letter delivered by UPS Next Day Air. The notice explained the problem, complaints received, and requested the consignee discard or destroy all affected devices. If the consignee further distributed the product, they were directed to forward a copy of the notice to those parties.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.