Food, drugs, devices › Draeger Medical, Inc.
Device recall: Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and tran
Draeger Medical, Inc. (Telford, PA) initiated this device recall on 22 Dec 2015; FDA lists 2 product records under event 72914, 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. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 5 Apr 2017. Initiation: voluntary: firm initiated. Draeger Medical, Inc. has 30 enforcement events on this register, with a median of 1 product record 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
Draeger Medical, Inc., Telford, PA.
Reason for recall
"Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating."
Distribution
"Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0691-2016 | Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support. | 0 | Class I | Terminated | 10 Feb 2016 |
| Z-0692-2016 | Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators. | 402 units (314 - Oxylog 3000; 88 - Oxylog 3000 Plus) | Class I | Terminated | 10 Feb 2016 |
Context
Other enforcement events for Draeger Medical, Inc.
All 30 events for Draeger Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating."
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: "Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Apr 2017. "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.