Quick Facts at a Glance
- Recall Date
- November 24, 2025
- Hazard Level
- HIGH
- Brand
- Draeger
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 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
- Anesthetic Vaporizer
- Model numbers
- Model No. M35054, UDI-DI: 04048675228059, Serial No. ASUK-0421, ASUK-0422, ASUK-0423, ASUK-0424, ASUK-0425, ASUK-0426 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 24, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A certain component of affected devices was not delivered within specification and contained impurities.
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 Draeger Vapor 2000 is a calibrated anesthetic vaporizer used in medical settings to deliver anesthetic gases. Healthcare providers rely on this device for safe anesthesia administration during surgical procedures.
Why This Is Dangerous
The hazard arises from a component that did not meet quality specifications, leading to the presence of harmful impurities. This defect may compromise patient safety during anesthesia.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers' ability to safely administer anesthesia, creating potential safety concerns for patients undergoing surgery.
Practical Guidance
How to identify if yours is affected
- Verify the model number and serial numbers on the device.
- Check the recall notification for affected units.
- Contact Draeger if unsure about the identification.
Where to find product info
Serial numbers can typically be found on the device's identification label, often located on the back or bottom of the unit.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements after following the recall instructions.
If the manufacturer is unresponsive
- Document all correspondence with Draeger.
- Reach out again via different communication methods (phone, email).
- Consider filing a complaint with the FDA if unresolved.
How to prevent similar issues
- Always check for product recalls before purchasing medical devices.
- Look for devices with recent certifications and safety approvals.
- Ensure you're informed about the manufacturer and their history.
Documentation advice
Keep copies of purchase receipts, recall notifications, and any communication with Draeger or healthcare providers.
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Product Details
The recalled product is the Draeger Vapor 2000 anesthetic vaporizer, Model No. M35054. Units were distributed worldwide, including multiple U.S. states such as California and Texas. The recall affects 431 units.
Key Facts
- 431 units recalled worldwide
- Impurities found in a component
- Patients should stop using immediately
- Class I recall due to high hazard risk
- Contact Draeger or healthcare provider for instructions
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Safety Guide
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