Draeger Oxylog 3000 plus ventilators, emergency and… recallZ-1440-2014 · Draeger Medical Systems, Inc. · initiated Mar 5, 2014
Class I Terminated All recalls posted in April 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draeger Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
Drager sent an Urgent Medical Device Recall letter dated February 2014 to affected customers. The letter identified the affected device, problem and actions to be taken. The notification directed customers to perform manual ventilation in the event of a failure. Drager plans to repair the affected devices free of charge. If you have any questions regarding the Recall letter please call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger ventilator please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Recall details
- Recall number
- Z-1440-2014
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Mar 5, 2014
- Posted by the FDA
- Apr 10, 2014
- Recalling firm
- Draeger Medical Systems, Inc.
- Quantity
- 3
- Product code
- BTL
- FDA submissions
- K103625
- Distribution
- USA Nationwide Distribution in the states of WI and NY.
Product description
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Code information (models, lots, serial numbers)
Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005
Other devices under the same FDA submission
1 device cleared under K103625 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Oxylog 3000plus 5704833Drägerwerk AG & Co. KGaA · Ventilator, Continuous, Facility Use4 deaths58 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page