The Recall Desk
CriticalFDA (Devices)·Z-0933-2026·Announced 2025-12-31

Vapor 2000 anesthetic vaporizers recalled over an out of specification component

Draeger is recalling 431 Vapor 2000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.

Plain-English summary

The Draeger Vapor 2000, an unheated calibrated anesthetic vaporizer, model M35054, is being recalled.

A certain component of affected devices was not delivered within specification and contained impurities.

The record lists 431 units carrying UDI-DI 04048675228059, with serial numbers listed in the enforcement record including ASUK-0421 through ASUK-0425. Distribution was worldwide, including nationwide in the United States across Alaska, California, Florida, Iowa, Kansas, Maryland, Maine, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, South Dakota and Tennessee. The FDA has classified the action as Class I, its most serious category.

Facilities should quarantine affected stock immediately and follow Draeger's instructions.

The recalled product

Product
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Manufacturer
Draeger, Inc.
Category
Medical Device — Anesthesia vaporizer
Hazard
Affected units
431

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No. M35054
  • UDI-DI: 04048675228059
  • Serial No. 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

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Draeger, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Draeger, Inc.

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Same hazard · out of specification

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