RegWardenFDA facility compliance records
Company

E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.

1 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2024: 1 recalls20172018201920202021202220231202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-03-13
    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).

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10055959-e-m-s-electro-medical-systems-hangzhou-c/

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