RegWardenFDA facility compliance records
Company

TZ MEDICAL, 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; 2016: 1 recalls1’13’142’151’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2016-07-07
    Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label.
  • Class IITerminated2015-10-14
    The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal
  • Class IITerminated2015-10-14
    During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k
  • Class IITerminated2013-04-30
    TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the fai…

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. “TZ MEDICAL, 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-9006202-tz-medical-inc/

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