Quick Facts at a Glance
- Recall Date
- September 9, 2025
- Hazard Level
- HIGH
- Brand
- Draeger
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Draeger
- Product type
- Anesthesia workstation
- Model numbers
- 8621600, ASTA-0307, ASTA-0309, ASTA-0311, ASTA-0349, ASTA-0350, ASTA-0409, ASTB-0048 +17 more
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 9, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Draeger, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Atlan A350XL is an anesthesia workstation used to ventilate patients during surgical or diagnostic procedures. It supports mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing, for adults, pediatric, and neonatal patients.
Why This Is Dangerous
A piston ventilator failure before use or a mechanical ventilation failure during operation can result in inadequate ventilation during anesthesia, potentially harming patients.
Industry Context
This recall is not described as part of a broader industry pattern in the data provided.
Real-World Impact
Health systems may need to replace or repair affected workstations promptly to avoid procedural delays and ensure safe patient ventilation.
Practical Guidance
How to identify if yours is affected
- Verify the model against 8621600 and listed ASTA/ASTB/ASTC/ASTD/ASTH variants.
- Confirm serial numbers match the US distribution list ASTA-0307, ASTA-0309, etc.
- Check whether the device was distributed in the listed international markets.
Where to find product info
Serial numbers/UDI can be found on the equipment label and accompanying documentation.
What timeline to expect
Remedy timelines are not specified; follow Draeger recall instructions for expected replacement or field actions.
If the manufacturer is unresponsive
- Document all contact attempts with Draeger.
- Escalate to hospital risk management and local regulatory bodies if the vendor is unresponsive.
How to prevent similar issues
- Verify device recalls before procurement.
- Maintain an updated inventory of anesthesia workstations and serials.
- Establish vendor recall communication protocols.
Documentation advice
Keep copy of the recall notice, serial numbers, purchase records, and all correspondence with Draeger.
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Product Details
Brand: Draeger. Product: Atlan A350XL anesthesia workstation. Model/Catalog Number: 8621600. Distribution: 25 US states listed; international distribution to Argentina, Australia, Belgium, Brazil, Chile, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam. Quantity: 223 units.
Reported Incidents
No injury counts or incident narratives are provided in the recall notice beyond the class I designation and the stated hazard. No specific injuries or deaths are mentioned in the available data.
Key Facts
- Model/ catalog number 8621600
- Distributed in 25 US states
- International distribution to 40+ countries
- Hazard: piston ventilator failure or mechanical ventilation failure
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Safety Guide
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