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Recall

Class I — Draeger, Inc.

Recalling firmDraeger, Inc.
Registered facilityDRAEGER, INC. (the firm's only registered facility)
ClassificationClass I
StatusOngoing
ReasonA certain component of affected devices was not delivered within specification and contained impurities.
ProductDraeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
Quantity188 units
DistributionWorldwide - 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, …
Initiated2025-11-24
Classified2025-12-23
Recall numberZ-0934-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Draeger, Inc. (Z-0934-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98002/

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