Vapor 2000 M35054Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04048675228059), received between Aug 18, 2022 and Jun 29, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K971923); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 24, 2025Open, Classified

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

   Z-0933-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Leak/Splash

  IT WAS REPORTED THAT THE ANESTHETIC AGENT SPRAYED OUT OF THE VAPORIZER DURING AN OPERATOR ATTEMPT TO FILL IT UP. AS PER REPORT, THE OPERATOR WAS NOT EXPOSED TO THE SUBSTANCE. REMARK: THE PARTICULAR AGENT INTENDED FOR USE WITH THIS DEVICE HAS A BOILING POINT OF 58°C / 136.4°F - IT SHOULD THUS NOT SPRAY OUT OF THE VAPORIZER AT ROOM TEMPERATURE. AT THE MOMENT, THE MANUFACTURER CANNOT EXCLUDE THE PRESENCE OF A MALFUNCTION OR USE ERROR AND THUS, THIS REPORT IS FILED IN ABUNDANCE OF CAUTION.

  Patient problems: Insufficient Information

  MAUDE report 25650431 ↗
• MalfunctionJun 29, 2026Leak/Splash

  IT WAS REPORTED THAT THE ANESTHETIC AGENT SPRAYED OUT OF THE VAPORIZER DURING AN OPERATOR ATTEMPT TO FILL IT UP. AS PER REPORT, THE OPERATOR WAS NOT EXPOSED TO THE SUBSTANCE. REMARK: THE PARTICULAR AGENT INTENDED FOR USE WITH THIS DEVICE HAS A BOILING POINT OF 58°C / 136.4°F - IT SHOULD THUS NOT SPRAY OUT OF THE VAPORIZER AT ROOM TEMPERATURE. AT THE MOMENT, THE MANUFACTURER CANNOT EXCLUDE THE PRESENCE OF A MALFUNCTION OR USE ERROR AND THUS, THIS REPORT IS FILED IN ABUNDANCE OF CAUTION.

  Patient problems: Insufficient Information

  MAUDE report 25650426 ↗
• MalfunctionOct 29, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE USER HAD THE CONCERN THAT THE APPROPRIATE GAS WAS NOT BEING DELIVERED, REMOVED THE VAPORIZER AND GAVE ADDITIONAL MEDICATION TO THE PATIENT. NO PATIENT CONSEQUENCE HAVE FINALLY OCCURRED FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Oversedation

  MAUDE report 20556562 ↗
• MalfunctionOct 29, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE USER HAD THE CONCERN THAT THE APPROPRIATE GAS WAS NOT BEING DELIVERED, REMOVED THE VAPORIZER AND GAVE ADDITIONAL MEDICATION TO THE PATIENT. NO PATIENT CONSEQUENCE HAVE FINALLY OCCURRED FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Oversedation

  MAUDE report 20555491 ↗
• InjuryDec 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  DRÄGER RECEIVED THE INITIAL INFORMATION ABOUT THIS EVENT VIA THE MULTI-VENDOR SERVICE OF GE. IT WAS REPORTED THAT TWO VAPORIZERS MANUFACTURED BY DRÄGER WERE USED IN CONNECTION WITH A GE ANESTHESIA DEVICE. THERE WAS AWARENESS OF THE PATIENT OCCURRING DURING SURGERY. AS PER REPORT, THE PATIENT EXPERIENCES POST-OPERATIVE COMPLICATIONS SUCH AS NIGHTMARES ETC. AS A CONSEQUENCE OF THE AWARENESS.

  Patient problems: Awareness During Anesthesia

  MAUDE report 18353695 ↗
• MalfunctionNov 3, 2023Structural Problem; Unintended Movement; Device Fell; Structural Problem; Unintended Movement; Device Fell

  IT WAS REPORTED THAT THE AXLE BETWEEN THE SUPPORT ARM AND THE FLANGE TUBE OF THE MOVITA SUPPLY UNIT HAD COME LOOSE ON ONE SIDE, CAUSING THE SUPPLY UNIT TO TILT. WHEN ATTEMPTING TO UNLOAD AND RELEASE THE AXLE, THE ATTACHED ÄNESTHESIA DEVICE (PERSEUS 500) JUMPED OUT OF ITS MOUNTING SPIGOT AND FELL OVER. THE ANESTHESIA DEVICE CONTINUED TO FUNCTION EVEN IN THIS SITUATION. NO SERIOUS INJURY OCCURRED; ONE PERSON SUFFERED A SLIGHT HEMATOMA ON THE FOOT.

  Patient problems: Hematoma

  MAUDE report 18063129 ↗
• MalfunctionOct 31, 2023

  ANESTHESIA MACHINE CHECK PERFORMED IN MORNING. ALL ELEMENTS OF TEST PASSED. 2.5% INSPIRED SEVOFLURANE MAINTAINED FOR ANESTHETIC, VENTILATOR DELIVERING PROGRAMMED TIDAL VOLUMES WITHOUT EVIDENCE OF LEAK. GLASS CHAMBER ON SEVOFLURANE VAPORIZER NOTED TO BE CRACKED AT BASE. ET AGENT READING 2.45%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038829 ↗
• InjuryAug 18, 2022Fracture; Activation Failure; Fracture; Activation Failure

  IT WAS REPORTED THAT THE CONTROL DIAL OF THE VAPORIZER "FELT LOOSE" AND THAT THE DOSAGE OF ANESTHETIC AGENT WAS LESS THAN EXPECTED. REPORTEDLY, THE PATIENT SHOWED SIGNS OF BEGINNING AWARENESS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15247314 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K971923. One submission often covers many models, so check the product and lot details in each record.

• Z-0934-2026 · Nov 24, 2025 · Open, Classified
  Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.