Stop using nowMedical device recall · FDA · Published April 10, 2025
AirLife Infant Heated Wire Circuit Recall: Disconnection Risk for Neonates
Vyaire Medical recalls AirLife Infant Heated Wire Circuit model AH165 due to risk of disconnection during use, which can cause severe health issues in neonates.
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.
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📍Recalling firmVyaire Medical26125 N Riverwoods Blvd · Mettawa, IL 60045-3420
“AirLife Infant Heated Wire Circuit Recall: Disconnection Risk for Neonates.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52473-airlife-infant-heated-wire-circuit-recall-disconnection-risk-for-neonates. Based on FDA recall #Z-1697-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1697-2025%22&limit=1).
The FDA announced on April 10, 2025, that Vyaire Medical is recalling AirLife Infant Heated Wire Circuit model AH165 due to a Class I hazard. Adapters may disconnect during setup or use, potentially interrupting ventilation for neonates.
According to the FDA, 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.
Context
GovInfoNow's records show Vyaire Medical has 9 other recalls on record since July 18, 2017. Other recent recalls of similar products include Medline Breathing Circuits Recall: Risk of Infant Breathing Failure (July 13, 2026), Medline Neonatal Breathing Circuits Risk of Sporadic Failure in Infants (July 13, 2026), and Medline Hudson RCI Breathing Circuits Recall: Risk of Infant Respiratory Failure (July 13, 2026).
How to tell if you have this one
Check for the model number AH165 on the device. The lot numbers include 0004240347, 0004240348, 0004252021, and other specific serial numbers listed in the recall notice.
Brand
AirLife
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
Recall number
Product, codes & lots
Quantity
Z-1697-2025
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.; 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
Immediately stop using the AirLife Infant Heated Wire Circuit model AH165 if it is connected to a ventilator.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The lot numbers include 0004240347, 0004240348, 0004252021, 0004253194, 0004253470, 0004255176, 0004260100, 0004262183, 0004262987, 0004263371, 0004292077, 0004300092, and 0004301668.
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.
Official source: FDA Recall #Z-1697-2025 (April 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1697-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.