CLASS I ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report
VentStar Flex recalled by Draeger
Draeger is recalling VentStar Flex 220, distributed nationwide in the US. The recall was initiated on 12 Mar 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1493-2025
- FDA event ID
- 96342
- Recalling firm
- Draeger, Telford, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Mar 2025
- FDA classified
- 3 Apr 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 12 Mar 2025 | Recall initiated by company | |
| 3 Apr 2025 | Classified by FDA | +22 days |
| 9 Apr 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The potential for cracks forming in the breathing circuit hose.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable
Where it was distributed
Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United Kingdom
Questions about this recall
Why was it recalled?
The potential for cracks forming in the breathing circuit hose.
Which lots are affected?
Model/Catalog Number: MP00355; UDI Number 04048675248996; All lot numbers
Where was it sold?
Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 96342| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Anesthesia Circuit Kit Flex recalled by Draeger | Draeger | Device Malfunction | Nationwide | |
| CLASS I | Anesthesia Circuit Kit Flex EPA recalled by Draeger | Draeger | Device Malfunction | Nationwide | |
| CLASS I | Anesthesia Circuit Kit Flex recalled by Draeger | Draeger | Device Malfunction | Nationwide | |
| CLASS I | Anesthesia Circuit Kit Flex recalled by Draeger | Draeger | Device Malfunction | Nationwide | |
| CLASS I | Anesthesia Circuit Kit Flex (P)2 recalled by Draeger | Draeger | Device Malfunction | Nationwide | |
| CLASS I | ID Circuit Flex recalled by Draeger | Draeger | Device Malfunction | Nationwide |
More recalls from Draeger
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|---|---|---|---|---|---|
| Device | CLASS I | VentStar Resus Neo recalled by Draeger | Draeger | Packaging Defects | Nationwide |
| Device | CLASS I | Atlan A350 recalled by Draeger | Draeger | Device Malfunction | 11 states |
| Device | CLASS I | Atlan A350XL recalled by Draeger | Draeger | Device Malfunction | 11 states |
| Device | CLASS I | Vapor 3000. Unheated, calibrated anesthetic vaporizer recalled | Draeger | Potency & Assay | Nationwide |
| Device | CLASS I | Vapor 2000. Unheated, calibrated anesthetic vaporizer recalled | Draeger | Potency & Assay | Nationwide |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |