Food, drugs, devices › Vyaire Medical
Device recall: AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
Vyaire Medical (Mettawa, IL) initiated this device recall on 10 Jan 2024; FDA lists 9 product records under event 93821, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 11% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Vyaire Medical has 12 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Vyaire Medical, Mettawa, IL.
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."
Distribution
"Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1057-2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000, | 106,656 units | Class I | Ongoing | 6 Mar 2024 |
| Z-1058-2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001 | 66,078 units | Class I | Ongoing | 6 Mar 2024 |
| Z-1059-2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F | 8,220 units | Class I | Ongoing | 6 Mar 2024 |
| Z-1060-2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2 | 3,636 units | Class I | Ongoing | 6 Mar 2024 |
| Z-1061-2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005 | 3,683,407 units | Class I | Ongoing | 6 Mar 2024 |
| Z-1062-2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F | 2,070 units | Class I | Ongoing | 6 Mar 2024 |
| Z-1063-2024 | AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2 | 4,572 units | Class I | Ongoing | 6 Mar 2024 |
| Z-1064-2024 | AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017 | 1,020,330 units | Class I | Ongoing | 6 Mar 2024 |
| Z-1065-2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004 | 1,800,000 units | Class I | Ongoing | 6 Mar 2024 |
Context
Other enforcement events for Vyaire Medical
All 12 events for Vyaire Medical
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.