The Recall Desk
SevereFDA (Devices)·Z-2018-2023·Announced 2023-07-19

Oxylog 3000 Plus ventilator may stop working during operation

The Draeger Oxylog 3000 Plus emergency and transport ventilator may stop working when transitioning from battery to AC operation. Approximately 300 units distributed nationwide and internationally are affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this as a Class I recall, which requires a minimum severity of 4. Although no deaths or reported injuries are documented in the source, the failure of critical life-support equipment during operation presents significant clinical risk.

Plain-English summary

The Draeger Oxylog 3000 Plus is an emergency and transport ventilator used in clinical and emergency settings. The FDA has issued a Class I recall for this device.

The manufacturer, Draeger Medical, Inc., identified instances where the Oxylog 3000 Plus stopped working when in use during the transition from battery to AC operation. This functional failure represents a critical issue for a device used in emergency medical care.

The recall affects 300 units distributed nationwide and to numerous countries worldwide. Affected units have catalog numbers 5704811 and 5704813, and the recall covers all serial numbers of these models.

The recalled product

Product
Oxylog 3000 Plus emergency and transport ventilator
Manufacturer
Draeger Medical, Inc.
Hazard
  • device-failure
  • power-transition-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Catalog No. 5704811 & 5704813
  • UDI-DI: 04048675398295
  • All Serial No.

Distribution

Distributed nationwide across the United States.