Z-0934-2026Class I

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer

Name: Z-0934-2026 Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer
Creator: Draeger, Inc.
Published: 2025-11-24
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2025-11-24 / Open, Classified

FDA source

Draeger, Inc. began a recall of Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer on 2025-11-24. FDA classified it as Class I and gives the reason as "A certain component of affected devices was not delivered within specification and contained impurities". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0934-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-11-24
Posted: 2025-12-23
Recalling firm: Draeger, Inc.
Product: Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
Product code: CAD Vaporizer, Anesthesia, Non-Heated
Reason for recall: A certain component of affected devices was not delivered within specification and contained impurities.
FDA 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 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 [email protected] or phone at 267-664-1131.
Quantity in commerce: 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, Israel, Japan, Kenya, Mexico, Nepal, Norway, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates, Vietnam.
Product codes and lots: Model No. M36500; UDI-DI: 04048675301363; Serial No. ASUK-1181,ASUK-1186,ASUK-1187,ASUK-1196,ASUK-1197,ASUK-1198,ASUK-1199,ASUK-1200, ASUK-1201,ASUK-1202,ASUK-1203,ASUK-1204,ASUK-1205,ASUK-1206,ASUK-1207,ASUK-1208, ASUK-1209,ASUK-1210,ASUK-1211,ASUK-1212,ASUK-1213,ASUK-1214,ASUK-1215,ASUK-1216, ASUK-1217,ASUK-1218,ASUK-1219,ASUK-1220,ASUK-1590,ASUK-1591,ASUK-1592,ASUK-1611, ASUK-1613,ASUK-1616,ASUK-1617,ASUK-1618,ASUK-1619, ASUK-0241,ASUK-0242,ASUK-0243,ASUK-0244,ASUK-0245,ASUK-0246,ASUK-0247,ASUK-0248, ASUK-0249,ASUK-0250,ASUK-0451,ASUK-0452,ASUK-0453,ASUK-0454,ASUK-0455,ASUK-0456, ASUK-0457,ASUK-0458,ASUK-0459,ASUK-0460,ASUK-0461,ASUK-0462,ASUK-0463,ASUK-0464, ASUK-0465,ASUK-0466,ASUK-0467,ASUK-0468,ASUK-0469,ASUK-0470,ASUK-0471,ASUK-0472, ASUK-0473,ASUK-0474,ASUK-0475,ASUK-0476,ASUK-0477,ASUK-0478,ASUK-0479,ASUK-0480, ASUK-0481,ASUK-0482,ASUK-0483,ASUK-0484,ASUK-0486,ASUK-0487,ASUK-0488,ASUK-0489, ASUK-0490,ASUK-0491,ASUK-0492,ASUK-0493,ASUK-0494,ASUK-0495,ASUK-0496,ASUK-0497, ASUK-0498,ASUK-0499,ASUK-0500,ASUK-0501,ASUK-0502,ASUK-0503,ASUK-0504,ASUK-0505, ASUK-0506,ASUK-0507,ASUK-0508,ASUK-0509,ASUK-0510,ASUK-0511,ASUK-0512,ASUK-0513, ASUK-0514,ASUK-0515,ASUK-0516,ASUK-0517,ASUK-0518,ASUK-0519,ASUK-0520,ASUK-0521, ASUK-0522,ASUK-0523,ASUK-0524,ASUK-0525,ASUK-0526,ASUK-0527,ASUK-0528,ASUK-0529, ASUK-0530,ASUK-0531,ASUK-0532,ASUK-0533,ASUK-0534,ASUK-0535,ASUK-0536,ASUK-0537, ASUK-0538,ASUK-0539,ASUK-0540,ASUK-0541,ASUK-0542,ASUK-0543,ASUK-0544,ASUK-0545, ASUK-0546,ASUK-0547,ASUK-0548,ASUK-0549,ASUK-0550,ASUK-0551,ASUK-0552,ASUK-0553, ASUK-0554,ASUK-0555,ASUK-0556,ASUK-0557,ASUK-0558,ASUK-0559,ASUK-0560,ASUK-1181, ASUK-1182,ASUK-1183,ASUK-1184,ASUK-1185,ASUK-1191,ASUK-1192,ASUK-1193,ASUK-1194, ASUK-1195,ASUK-1581,ASUK-1582,ASUK-1583,ASUK-1584,ASUK-1585,ASUK-1586,ASUK-1587, ASUK-1588,ASUK-1589,ASUK-1593,ASUK-1594,ASUK-1595,ASUK-1596,ASUK-1597,ASUK-1598, ASUK-1599,ASUK-1600,ASUK-1602,ASUK-1612,ASUK-1614,,ASUK-1615,ASUK-1620.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0934-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0933-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23
Z-0934-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23

Product code CAD

K971923Class IIDrager-Vapor 2000Draeger Medical, Inc. / cleared 1997-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)