VentStar Breathing Bag Set Recalled for Loose Circuit Connections
Draeger Medical is recalling VentStar breathing bag sets nationwide due to loose glued connections in the breathing circuit. Connections can detach before or during ventilation.
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 Class I medical device recall. The hazard involves glued connections that can detach during use in a breathing apparatus, a critical respiratory device. Class I classification mandates a minimum severity score of 4.
Plain-English summary
Draeger Medical, Inc. is recalling VentStar breathing bag Set (P) 110, model MP00384. This device is distributed nationwide in the United States, with all production lots affected.
The glued connections of the breathing circuit can become loose before or during ventilation. This may result in partial or complete detachment of circuit pieces.
The FDA has classified this as a Class I recall, indicating the seriousness of this defect in a critical medical device.
The recalled product
- Product
- VentStar breathing bag Set (P) 110, MP00384
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 25
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 (2)
- UDI-DI: 04048675421870
- All lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 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 22 products in this recall →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 · connection failure
See all →- HighRapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
FDA (Devices) · 2026-07-22
- HighBD Connecta stopcock Port C may over thread rather than tightening
FDA (Devices) · 2026-06-24
- SevereHalyard CATH LAB Kit Due to Syringe Adapter Disconnection Risk
FDA (Devices) · 2026-05-13
- SevereHalyard SAMMC Angiography Kit syringe rotating adapter unwinding recall
FDA (Devices) · 2026-05-13
- SevereHalyard Cardiac Catheterization Tray Kits Recalled for Connection Risk
FDA (Devices) · 2026-05-13
Similar recalls
- SevereDraeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- HighDräger VentStar Basic Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- SevereDraeger Medical Recalls VentStar Basic 180 Breathing Circuits
FDA (Devices) · 2019-01-30
- CriticalDraeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- SevereDraeger VentStar Anesthesia Breathing Circuits Recalled for Detachment Risk
FDA (Devices) · 2021-03-17
- SevereDraeger Medical Recalls VentStar Watertrap Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30