Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
FDA device recall Z-0934-2026 · posted 2025-12-23 · Open, Classified
Recall details
- Recalling firm
- Draeger, Inc.
- Reason for recall
- A certain component of affected devices was not delivered within specification and contained impurities.
- Action taken
- 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 devices to ensure awareness and forward the notice if product was further distributed. Questions regarding operation of devices are to be directed to Drager Service Technical Support at 1-800-437-2437 (Option 2, 2, 2). Questions about the recall notice are to be directed to Michael Kelhart via email at mike.kelhart@draeger.com or phone at 267-664-1131.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- CAD
- Quantity affected
- 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, C
- Date initiated
- 2025-11-24
- Date posted
- 2025-12-23
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRAGER-VAPOR 2000 (K971923) | Draeger Medical, Inc. | 1997-09-16 |