FDA-Device2025-12-31Class IPROCESSING DEFECT
Draeger Vapor 3000 anesthetic vaporizer recalled for component impurities
What this means
Draeger, Inc. is recalling certain Vapor 3000 anesthetic vaporizers (Model M36500) because a component inside was not built to specification and contains impurities. This affects 188 units with specific serial numbers distributed worldwide. No injuries have been reported.
- Check if your device serial number matches the affected list (ASUK-0241 through ASUK-1620)
- Contact Draeger, Inc. immediately if your vaporizer is affected
- Do not use the device until you confirm it is not on the recall list
- Follow Draeger's instructions for inspection, repair, or replacement
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
188 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0934-2026Want us to check the next one for you?
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