CLASS II Device recall · Reported 13 Dec 2023 · FDA Enforcement Report
vyaire Flexible Patient Circuit, 3100A recalled by Vyaire Medical
Vyaire Medical is recalling vyaire Flexible Patient Circuit, 3100A, distributed in Florida. The recall was initiated on 27 Oct 2023 and the FDA has classified it as Class II.
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-0489-2024
- FDA event ID
- 93332
- Recalling firm
- Vyaire Medical, Mettawa, IL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 27 Oct 2023
- FDA classified
- 5 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 27 Oct 2023 | Recall initiated by company | |
| 5 Dec 2023 | Classified by FDA | +39 days |
| 13 Dec 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
Product as listed by the FDA
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Where it was distributed
US: Florida
Questions about this recall
Why was it recalled?
Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
Which lots are affected?
UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792
Where was it sold?
US: Florida
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 93332| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | vyaire Flexible Patient Circuit, 3100A recalled by Vyaire Medical | Vyaire Medical | Other | FL |
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 CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |