CLASS I ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report

AirLife Infant Heated Wire Circuit recalled by Vyaire Medical

Vyaire Medical is recalling AirLife Infant Heated Wire Circuit, distributed nationwide in the US. The recall was initiated on 10 Apr 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot 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

Quantity recalled1895

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1697-2025
FDA event ID: 96664
Recalling firm: Vyaire Medical, Mettawa, IL
Classification: Class I
Status: Ongoing
Recall initiated: 10 Apr 2025
FDA classified: 9 May 2025
Reported: 21 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

10 Apr 2025	Recall initiated by company
9 May 2025	Classified by FDA	+29 days
21 May 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96664

Reported	Class	Recall	Company	Reason	Where
21 May 2025	CLASS I	AirLife Infant Heated Wire Circuit recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide

More recalls from Vyaire Medical

All 63

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS I	AirLife Infant Heated Wire Circuit recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	GmbH, Vyaire Twin Tube sample line recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, Oxygen Reservoir, without Mask recalled	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide

Other CPAP & Ventilators recalls

All 552

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide