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Vapor 3000 M36500Recalls & reported problems

Drägerwerk AG & Co. KGaA · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048675301363), received between Jan 23, 2026 and Jan 23, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Gas Output Problem” (1 report).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Nov 24, 2025Open, Classified

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

    Z-0934-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Gas Output Problem1
  • Inaccurate Delivery1

Patient problems

  • Oversedation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 23, 2026Gas Output Problem; Inaccurate Delivery

    BY MEANS OF AN UFR, DRÄGER WAS NOTIFIED ABOUT AN ADVERSE EVENT OCCURRED DURING USE OF AN ANESTHETIC GAS VAPORIZER OF TYPE DRÄGER VAPOR 3000. A SIGNIFICANT OVERDOSE WAS REPORTEDLY OBSERVED DURING A SURGICAL PROCEDURE; THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE, REQUIRING THE ADMINISTRATION OF ATROPINE FOR STABILIZATION. IT WAS MENTIONED THAT NO FINAL HEALTH CONSEQUENCES WERE RESULTING FROM THE EVENT.

    Patient problems: Oversedation

    MAUDE report 24159522 ↗

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-0933-2026 · Nov 24, 2025 · Open, Classified
    Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

Other Vaporizer, Anesthesia, Non-Heated devices

All Vaporizer, Anesthesia, Non-Heated devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.