Draeger Recalls Oxylog 3000 Pediatric Patient Circuits Due to Leakage
Draeger Medical is recalling Oxylog 3000 disposable pediatric patient circuits because isolated episodes of leakage were found at the check valve.
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: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Draeger Medical, Inc. is recalling the Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number 5704964. The recall involves 42,922 units worldwide, with 1,530 units distributed in the United States. The product is used with the Dräger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
The recall was initiated due to isolated episodes of leakage at the check valve. The affected units were distributed nationwide in the US, including in Alaska, California, Florida, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
Consumers and healthcare facilities should stop using the affected patient circuits and contact Draeger Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
- Manufacturer
- Draeger Medical, Inc.
- Hazard
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 (1)
- Catalog Number: 5704964
Distribution
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 · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- SevereDraeger Oxylog 3000 Ventilators Recalled for Software Error
FDA (Devices) · 2016-02-10
- HighDräger VentStar Basic Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- HighDraeger VentStar Watertrap Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- SevereDraeger Oxylog 3000 Plus Ventilators Recalled Due to Potentiometer Fault
FDA (Devices) · 2014-04-16
- SevereDraeger Oxylog 2000 Plus Ventilator Recalled for Malfunction
FDA (Devices) · 2016-02-10