CLASS I Device recall · Reported 16 Apr 2014 · FDA Enforcement Report
Draeger Oxylog 3000 plus ventilators, emergency recalled
Draeger Medical Systems is recalling Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator, distributed nationwide in the US. The recall was initiated on 5 Mar 2014 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-1440-2014
- FDA event ID
- 67677
- Recalling firm
- Draeger Medical Systems, Telford, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Mar 2014
- FDA classified
- 10 Apr 2014
- Reported
- 16 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 5 Mar 2014 | Recall initiated by company | |
| 10 Apr 2014 | Classified by FDA | +36 days |
| 16 Apr 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
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
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Where it was distributed
USA Nationwide Distribution in the states of WI and NY.
Questions about this recall
Why was it recalled?
The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
Which lots are affected?
Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005
Where was it sold?
USA Nationwide Distribution in the states of WI and NY.
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.
More recalls from Draeger Medical Systems
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| Device | CLASS II | Infinity Central Station recalled by Draeger Medical Systems | Draeger Medical Systems | Device Malfunction | Nationwide |
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| Device | CLASS II | Draeger Infinity CentralStation (ICS) recalled | Draeger Medical Systems | Device Malfunction | Nationwide |
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| 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 |