HIGH

Draeger Vapor 2000 Anesthetic Vaporizer Recalled Over Impurities

Draeger, Inc. recalled 431 units of the Vapor 2000 anesthetic vaporizer on November 24, 2025. A component of the devices contained impurities and did not meet specifications, posing a high hazard risk. Healthcare providers and patients should cease use immediately and follow recall instructions.

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

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

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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.

The Hazard

The recall stems from a component of the vaporizer that failed to meet specifications and contained impurities. This defect poses a significant health risk to patients undergoing anesthesia.

Reported Incidents

No specific injuries or incidents have been reported in connection with this recall. The FDA classified this recall as Class I, indicating a high risk to health.

What to Do

Patients and healthcare providers should stop using the Draeger Vapor 2000 immediately. Contact Draeger, Inc. or your healthcare provider for further instructions and follow the recall process outlined in the notification letter.

Contact Information

For more information, contact Draeger, Inc. at their official website or refer to the recall notification letter. Additional details can be found on the FDA website.

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 Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
Model No. M35054
UDI-DI: 04048675228059
Serial No. ASUK-0421
ASUK-0422
ASUK-0423
+15 more
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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