RegWardenFDA facility compliance records
Company

DEFIBTECH, LLC

6 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2020: 1 recalls; 2023: 1 recalls; 2024: 2 recalls; 2025: 2 recalls20172018201912020202120221202322024220252026
  • Recalls (6)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2025-03-18
    It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French…
  • Class IIOngoing2025-03-18
    It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French…
  • Class IIOngoing2024-10-14
    Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are wi…
  • Class IOngoing2024-07-12
    Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.
  • Class IIOngoing2023-02-14
    A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
  • Class IITerminated2020-04-27
    A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.

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. “DEFIBTECH, LLC — 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-9048526-defibtech-llc/

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