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AIR-FLOW FT-230-2B-302Recalls & reported problems

E.M.S. Electro Medical Systems S.A. · AIRFLOW One · Class 2

3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
3

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 3 still open.

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. Mar 13, 2024Open, Classified

    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

    Z-1686-2024 · Root cause: Process control · FDA record ↗

  2. Mar 13, 2024Open, Classified

    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

    Z-1687-2024 · Root cause: Process control · FDA record ↗

  3. Mar 13, 2024Open, Classified

    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

    Z-1688-2024 · Root cause: Process control · FDA record ↗

Other Scaler, Ultrasonic devices

All Scaler, Ultrasonic devices →

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