Z-1697-2025Class I

Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software...

Name: Z-1697-2025 Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software...
Creator: Vyaire Medical
Published: 2025-04-10
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2025-04-10 / Open, Classified / root cause: design

FDA source

Vyaire Medical began a recall of Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant... on 2025-04-10. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1697-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-04-10
Posted: 2025-05-09
Recalling firm: Jaeger Medical GmbH
Product: Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator.
Product code: BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 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 [email protected].
Quantity in commerce: 1895
Distribution: Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
Product codes and lots: Lot Code: Lot/Serial Number(s): 0004240347 0004240348 0004252021 0004253194 0004253470 0004255176 0004260100 0004262183 0004262987 0004263371 0004292077 0004300092 0004301668 UDI-DI AirLife Label Each: 10889483595862 Case: 30889483595866 Vyaire Label Each: 10190752145139 Case: 50190752145137

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1697-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1697-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09
Z-1698-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-09

Product code BZE

K151303Class IIAirLife Infant Heated Wire CircuitCare Fusion / cleared 2016-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)