Recall Z-0934-2026 ยท CAD Vaporizer, Anesthesia, Non-Heated
Draeger, Inc.
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
| Date | Dec 23, 2025 (initiated Nov 24, 2025) |
| Status | Open, Classified |
| Reason | A certain component of affected devices was not delivered within specification and contained impurities. |
| Root cause | Under Investigation by firm |
| Action | Consignees were mailed an Urgent Medical Device Recall notification dated November 2025. The notification recommends that consignees do not use affected vaporizers and return the provided reply card to confirm this. A Draeger representative will contact consignees to arrange replacement of affected vaporizers. If affected vaporizers have been placed into clinical use, Draeger asks that consignees clean the breathing system of the anesthesia device according to the IFU and use of inspiratory filters is recommended. Consignees are to share the recall notification with all users of affected devic |
| Quantity | 188 units |
| Distribution | 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, Isr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971923 | DRAGER-VAPOR 2000 Draeger Medical, Inc., Sep 16, 1997 |