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
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
- 8211500, ASTB-0181, ASTC-0005, ASTC-0006, ASTC-0007, ASTD-0244, ASTD-0259, ASTE-0180 +21 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 A350 is an anesthesia workstation used to deliver inhalational anesthesia and to ventilate patients during surgery or diagnostic procedures. It is designed for adults, pediatrics, and neonates. The device supports mechanical ventilation and spontaneous breathing modes.
Why This Is Dangerous
A piston ventilator failure before use or a failure during mechanical ventilation can compromise patient ventilation and safety during anesthesia.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
Hospitals may need to quarantine affected units and switch to alternative ventilation methods until replacements or repairs are arranged. The recall covers 530 units across multiple states and many countries, indicating a significant distribution footprint.
Practical Guidance
How to identify if yours is affected
- Verify the device is the Atlan A350 with model 8211500.
- Check serial numbers distributed in the US, such as ASTB-0181, ASTC-0005, ASTC-0006, ASTC-0007, ASTD-0244, etc.
- Confirm the UDI or lot information 04048675556176 where available.
Where to find product info
Model numbers and serial numbers appear on the device label and in the device documentation; UDI-DI may be listed in the recall notice.
What timeline to expect
Recall remediation and potential replacement or service actions are typically outlined by the manufacturer; timelines vary by institution.
If the manufacturer is unresponsive
- Document all attempts to contact Draeger and the facility's risk management team.
- Escalate to the hospital's compliance office if the manufacturer is unresponsive.
- File a report with the local health authority if patient safety concerns persist.
How to prevent similar issues
- In future purchases, verify vendor recall status and ensure device labeling includes model and serial numbers.
- Maintain an up-to-date inventory of critical medical devices and their recall status.
- Engage hospital biomedical engineering for routine verification of device integrity and service history.
Documentation advice
Keep copies of the recall notice, manufacturer instructions, device serial numbers, and all correspondence with the vendor.
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Product Details
Model/Catalog Number: 8211500. Quantity: 530 units. Distribution: 25 U.S. states listed; addresses include AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Exports: 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. Imported from Draer?
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed to 25 U.S. states
- Shipped to more than 30 countries
- Imported from Draegerwerk AG & Co. KGaA
- Hazard: piston ventilator failure before use or during use
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Safety Guide
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