CLASS I ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report
AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical
Vyaire Medical is recalling AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2, distributed nationwide in the US. The recall was initiated on 10 Jan 2024 and the FDA has classified it as Class I.
Check your package
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-1063-2024
- FDA event ID
- 93821
- Recalling firm
- Vyaire Medical, Mettawa, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 10 Jan 2024
- FDA classified
- 24 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Device type
- Masks, Gloves & PPE
Timeline
| 10 Jan 2024 | Recall initiated by company | |
| 24 Feb 2024 | Classified by FDA | +45 days |
| 6 Mar 2024 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Product as listed by the FDA
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
Where it was distributed
Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
Questions about this recall
Why was it recalled?
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Which lots are affected?
UDI/DI Case: 50190752114164, Each: 10190752114166; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
Where was it sold?
Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
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 21 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
8 other products · FDA event 93821This product is part of a recall event; the main page for the event is AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical | Vyaire Medical | Mold | Nationwide | |
| CLASS I | AirLife Adult Manual Resuscitator recalled by Vyaire Medical | Vyaire Medical | Mold | Nationwide | |
| CLASS I | AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical | Vyaire Medical | Mold | Nationwide | |
| CLASS I | AirLife Adult Manual Resuscitator, Oxygen Reservoir recalled | Vyaire Medical | Mold | Nationwide | |
| CLASS I | AirLife Adult Manual Resuscitator, Oxygen Reservoir recalled | Vyaire Medical | Mold | Nationwide | |
| CLASS I | AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical | Vyaire Medical | Mold | Nationwide | |
| CLASS I | AirLife Adult Manual Resuscitator, Oxygen Reservoir, without Mask recalled | Vyaire Medical | Mold | Nationwide | |
| CLASS I | AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical | Vyaire Medical | Mold | Nationwide |
More recalls from Vyaire Medical
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | AirLife Infant Heated Wire Circuit recalled by Vyaire Medical | Vyaire Medical | Device Malfunction | Nationwide |
| Device | CLASS I | AirLife Infant Heated Wire Circuit recalled by Vyaire Medical | Vyaire Medical | Device Malfunction | Nationwide |
| Device | CLASS I | GmbH, Vyaire Twin Tube sample line recalled by Vyaire Medical | Vyaire Medical | Other | Nationwide |
| Device | CLASS I | AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical | Vyaire Medical | Mold | Nationwide |
| Device | CLASS I | AirLife Adult Manual Resuscitator, Oxygen Reservoir, without Mask recalled | Vyaire Medical | Mold | Nationwide |
Other Masks, Gloves & PPE recalls
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|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&m Halyard | Other | Nationwide |