RegWardenFDA facility compliance records
Company

Z-MEDICA, LLC

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

Recalls by year

FDA actions on record by year2017: 2 recalls; 2021: 1 recalls220172018201920201202120222023202420252026
  • Recalls (3)

Registered facilities (2)

Recalls & enforcement

  • Class IITerminated2021-09-22
    Lack of Packaging seal integrity may result in a sterile barrier breach.
  • Class IITerminated2017-11-17
    A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it con…
  • Class IITerminated2017-05-17
    Packaging breach may compromise sterility

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. “Z-MEDICA, 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-9048106-z-medica-llc/

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