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U.S. Department of Health and Human Services

Class 1 Device Recall AirLife

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 Class 1 Device Recall AirLifesee related information
Date Initiated by FirmApril 10, 2025
Date PostedMay 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1698-2025
Recall Event ID 96664
510(K)NumberK151303 
Product Classification Heater, breathing system w/wo controller (not humidifier or nebulizer - Product Code BZE
ProductBrand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for respiratory gas between the patient and a ventilator.
Code Information Lot Code: Lot/Serial Number(s): 0004247924 0004247925 0004252940 0004252941 0004256292 0004256293 0004256294 0004256295 0004272325 0004272868 0004278978 0004279156 0004280036 0004285304 0004288036 0004289514 UDI-DI: AirLife Label Each: 10889483595909 Case: 30889483595903 Vyaire Label: Each: 10190752145160 Case: 50190752145168
FEI Number 3013421741
Recalling Firm/
Manufacturer		 Vyaire Medical
26125 N Riverwoods Blvd
Mettawa IL 60045-3420
Manufacturer Reason
for Recall		Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
FDA Determined
Cause 2		Component design/selection
ActionOn April 10, 2025, the firm notified customers via emailed letters titled URGENT: MEDICAL DEVICE RECALL. Customers are instructed to examine their inventory for the affected lots of product. Product in inventory should be quarantined. For in-use product - 1) For affected product in use that is utilizing the adaptor connection, immediately stop use of the product. 2) For affected product in use that is not utilizing the adaptor connection, ventilator circuit may continue to be utilized. Customers were provided with additional precautions to take to ensure proper function. Customers can choose between returning or destroying affected product. Firm will provide replacement product. If you have any questions regarding this field action, please call AirLife at 1-800-433-2797, or e-mail at productquality@myairlife.com.
Quantity in Commerce3053
DistributionWorldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BZE
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