CLASS II Device recall · Reported 17 Mar 2021 · FDA Enforcement Report
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets recalled
Draeger Medical is recalling VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets, distributed nationwide in the US. The recall was initiated on 29 Jan 2021 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-1179-2021
- FDA event ID
- 87267
- Recalling firm
- Draeger Medical, Telford, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jan 2021
- FDA classified
- 5 Mar 2021
- Reported
- 17 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- CPAP & Ventilators
Timeline
| 29 Jan 2021 | Recall initiated by company | |
| 5 Mar 2021 | Classified by FDA | +35 days |
| 17 Mar 2021 | 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
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Which lots are affected?
All lots
Where was it sold?
US Nationwide distribution.
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
3 other products · FDA event 87267This product is part of a recall event; the main page for the event is ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets recalled | Draeger Medical | Packaging Defects | Nationwide | |
| CLASS II | VentStar Anesthesia (N) recalled by Draeger Medical | Draeger Medical | Packaging Defects | Nationwide | |
| CLASS II | VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets recalled | Draeger Medical | Packaging Defects | Nationwide |
More recalls from Draeger Medical
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Atlan A300 recalled by Draeger Medical | Draeger Medical | Device Malfunction | PA |
| Device | CLASS I | Atlan A300XL recalled by Draeger Medical | Draeger Medical | Device Malfunction | PA |
| Device | CLASS I | Atlan A350 recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Atlan A350XL recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Dr¿ger Perseus A500 Anesthesia Workstation recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |