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.
The agency’s classification
FDA (Devices): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Affected units
- 300
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.
Related recalls
Same manufacturer · Draeger Medical, Inc.
See all →- SevereDraeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
FDA (Devices) · 2024-12-25
- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
FDA (Devices) · 2024-11-20
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
- SevereDräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns
FDA (Devices) · 2024-04-24
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
Similar recalls
- SevereDraeger Oxylog 2000 Plus Ventilator Recalled for Malfunction
FDA (Devices) · 2016-02-10
- SevereDraeger Oxylog 3000 Ventilators Recalled for Software Error
FDA (Devices) · 2016-02-10
- SevereDraeger Oxylog 3000 Plus Ventilators Recalled Due to Potentiometer Fault
FDA (Devices) · 2014-04-16
- SevereDraeger Recalls Oxylog 3000 Pediatric Patient Circuits Due to Leakage
FDA (Devices) · 2016-08-10
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
- HighDraeger Babylog VN600 Critical Care Ventilators Recalled for Software Defects
FDA (Devices) · 2021-06-09