Dräger VentStar Basic Breathing Circuits Recalled for Detachment Risk
Draeger Medical is recalling 1,525 VentStar Basic breathing circuits because a Y-piece may detach, causing a leak that hinders patient ventilation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Draeger Medical, Inc. is recalling 1,525 units of VentStar Basic (N) 180 Breathing Circuits/Anesthesia Sets (Order Number: MP00353). These products are intended for single use to conduct respiratory gases between an anesthesia machine or ventilator and a patient. The recall covers all lots and was distributed nationwide in the United States.
The recall was initiated because the Y-piece may become detached from the ventilation hose either before or during the ventilation process. This detachment causes a leak that can hinder the ventilation of the patient.
Healthcare facilities and users should stop using the affected products and contact Draeger Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 1,525
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Draeger Medical, Inc.
See all →- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
- SevereDraeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
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 · ventilation failure
See all →- SevereGE Healthcare Carestation 650c A1 Anesthesia System Ventilation Failure
FDA (Devices) · 2025-05-07
- SevereGE Healthcare CARESTATION Anesthesia Systems Volume Control Ventilation Failure
FDA (Devices) · 2025-05-07
- SevereGE Healthcare Carestation 650 A1 Anesthesia System Ventilation
FDA (Devices) · 2025-05-07
- SevereGE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall
FDA (Devices) · 2025-05-07
- SevereGE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall
FDA (Devices) · 2025-05-07
Similar recalls
- SevereDraeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- SevereDraeger Medical Recalls VentStar Basic 180 Breathing Circuits
FDA (Devices) · 2019-01-30
- SevereVentStar Basic Ventilator Recall: Risk of Breathing Circuit Detachment
FDA (Devices) · 2023-05-24
- CriticalDraeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- SevereDraeger VentStar Breathing Circuit Connections May Loosen During Use
FDA (Devices) · 2023-05-24
- SevereDraeger Medical Recalls 10 VentStar Anesthesia Breathing Circuits
FDA (Devices) · 2019-01-30