RegWardenFDA facility compliance records
Company

TRANSONIC SYSTEMS, INC.

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2015: 2 recalls; 2018: 1 recalls1’13’142’15’16’171’18’19’20’21’22’23’24’25’26
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2018-02-15
    The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
  • Class IITerminated2015-07-27
    Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
  • Class IITerminated2015-02-17
    Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac …
  • Class IITerminated2013-03-28
    Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

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. “TRANSONIC SYSTEMS, INC. — 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-1319030-transonic-systems-inc/

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