FDA-Device2025-12-31Class IPROCESSING DEFECT
Draeger Vapor 2000 anesthetic vaporizer recalled for internal component impurities
What this means
Draeger, Inc. is recalling certain Vapor 2000 anesthetic vaporizers because an internal component was manufactured with impurities and did not meet quality specifications. The affected units are identified by specific serial numbers and were distributed worldwide, including across the United States.
- Check if your Vapor 2000 vaporizer serial number matches the recall list (serial numbers starting with ASUK-)
- Contact Draeger, Inc. if you have an affected unit
- Do not use the device if you believe it is affected until you receive instructions from the manufacturer
The agency's original wording
Hazard
A certain component of affected devices was not delivered within specification and contained impurities.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS, MD, ME, MN, NY, OH, PA, RI, SD, TN, TX, UT, W and the countries of Argentina, Australia, Belgium, Brazil, Cambodia, China, Columbia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, Indonesia, Israel, Japan, Kenya, Mexico, Nepal, Norway, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates, Vietnam.
Affected count
431 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0933-2026Want us to check the next one for you?
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