RegWardenFDA facility compliance records
Facility

ZIEN MEDICAL TECHNOLOGIES LLC

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

Activity by year

FDA actions on record by year2015: 1 recalls; 2019: 1 inspections12015201620172018120192020202120222023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2015-08-18
    Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July …

FDA inspections (1)

  • NAI2019-02-11
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ZIEN MEDICAL TECHNOLOGIES LLC (FEI 3009756153) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009756153-zien-medical-technologies-llc/

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