RegWardenFDA facility compliance records
Facility

J&T Health and Wellness LLC

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

Activity by year

FDA actions on record by year2017: 1 inspections, 1 warning letters; 2018: 1 inspections; 2021: 1 inspections; 2023: 1 recalls, 1 inspections22017120182019202012021202222023202420252026
  • Recalls (1)
  • Inspections (4)
  • Warning letters (1)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2023-03-31
    In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.

FDA inspections (4)

  • VAI2023-10-18
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
  • VAI2021-07-30
    Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices · citations posted
  • VAI2018-08-24
    Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Project Evaluation: Devices; Postmarket Assurance: Devices · citations posted
  • OAI2017-08-04
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted

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.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

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. “J&T Health and Wellness LLC (FEI 1000525872) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000525872-j-t-health-and-wellness-llc/

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