RegWardenFDA facility compliance records
Facility

TENEX HEALTH

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

Activity by year

FDA actions on record by year2014: 1 recalls; 2017: 1 inspections; 2021: 1 inspections1’14’15’161’17’18’19’201’21’22’23’24’25’26
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2014-04-14
    The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.

FDA inspections (2)

  • NAI2021-09-01
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2017-08-21
    No Action Indicated · Compliance: 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. “TENEX HEALTH (FEI 1000135560) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000135560-tenex-health/

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