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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

AirLife Infant Heated Wire Circuits Recalled for Disconnection Risk

Agency Publication Date: May 9, 2025
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Summary

Vyaire Medical is recalling approximately 4,948 AirLife Infant Heated Wire Circuits (models AH165 and AH265) because the adapters may disconnect during setup or while in use. These devices are used to provide respiratory gas between a patient and a ventilator. There have been no reported injuries to date.

Risk

A disconnection in the breathing circuit can interrupt the flow of air to neonates, potentially causing severe health issues such as a lack of oxygen (hypoxia), excessive carbon dioxide in the blood (hypercapnia), and organ failure.

What You Should Do

  1. This recall affects AirLife Infant Heated Wire Circuits (model AH165) and Circuit Kits (model AH265) sold under the AirLife and Vyaire brands.
  2. To determine if your product is affected, check the model number and the lot number found on the product label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: AirLife Infant Heated Wire Circuit
Variants: AH165
Model / REF:
AH165
Lot Numbers:
0004240347
0004240348
0004252021
0004253194
0004253470
0004255176
0004260100
0004262183
0004262987
0004263371
0004292077
0004300092
0004301668
UDI:
10889483595862
30889483595866
10190752145139
50190752145137

AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min)

Product: AirLife Infant Heated Wire Circuit Kit
Variants: AH265
Model / REF:
AH265
Lot Numbers:
0004247924
0004247925
0004252940
0004252941
0004256292
0004256293
0004256294
0004256295
0004272325
0004272868
0004278978
0004279156
0004280036
0004285304
0004288036
0004289514
UDI:
10889483595909
30889483595903
10190752145160
50190752145168

Kit contains AH165 Circuit and AH290 Chamber.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96664
Status: Active
Manufacturer: Vyaire Medical
Sold By: Vyaire Medical; Hospital supply distributors
Manufactured In: United States
Units Affected: 2 products (1895; 3053)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.