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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Draeger Vapor 2000 and 3000 Vaporizers Recalled for Component Impurities

Agency Publication Date: December 23, 2025
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Summary

Draeger, Inc. is recalling 619 units of its Draeger Vapor 2000 and Vapor 3000 unheated, calibrated anesthetic vaporizers. The recall was initiated because a specific internal component was found to be out of technical specification and contains impurities. This contamination could interfere with the quality of anesthesia delivered during medical procedures or cause the device to malfunction.

Risk

Impurities within internal vaporizer components can lead to the delivery of contaminated anesthetic gas or cause the device to fail during use. This poses a critical safety risk to patients undergoing anesthesia, potentially resulting in serious injury or complication during surgery.

What You Should Do

  1. This recall involves Draeger Vapor 2000 (Model M35054) and Draeger Vapor 3000 (Model M36500) unheated anesthetic vaporizers.
  2. Identify if your device is affected by checking the model number and serial number on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Draeger Vapor 2000 Anesthetic Vaporizer
Variants: Unheated, Calibrated
Model / REF:
M35054
Serial Numbers (431):
ASUK-0421
ASUK-0422
ASUK-0423
ASUK-0424
ASUK-0425
ASUK-0426
ASUK-0602
ASUK-0603
ASUK-0705
ASUK-0706
ASUK-0707
ASUK-0708
ASUK-0721
ASUK-0722
ASUK-0723
ASUK-0724
ASUK-0725
ASUK-0726
ASUK-0727
ASUK-0728
ASUK-0729
ASUK-0730
ASUK-0731
ASUK-0732
ASUK-0733
ASUK-0734
ASUK-0735
ASUK-0736
ASUK-0737
ASUK-0738
ASUK-0739
ASUK-0740
ASUK-0749
ASUK-0761
ASUK-0762
ASUK-0763
ASUK-0764
ASUK-0765
ASUK-0766
ASUK-0767
ASUK-0768
ASUK-0769
ASUK-0770
ASUK-0835
ASUK-0836
ASUK-0837
ASUK-0972
ASUK-0973
ASUK-0974
ASUK-0975
UDI:
04048675228059

Units affected: 431

Product: Draeger Vapor 3000 Anesthetic Vaporizer
Variants: Unheated, Calibrated
Model / REF:
M36500
Serial Numbers (187):
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
UDI:
04048675301363

Units affected: 188

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98002
Status: Active
Manufacturer: Draeger, Inc.
Sold By: Authorized medical device distributors; Direct medical sales
Manufactured In: United States
Units Affected: 2 products (431 units; 188 units)
Distributed To: Alaska, California, Florida, Iowa, Kansas, Maryland, Maine, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah
Agency Last Updated: December 31, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.