RegWardenFDA facility compliance records
Facility

TERRAGENE SA

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

Activity by year

FDA actions on record by year2023: 1 recalls, 1 inspections, 1 warning letters; 2025: 1 recalls201720182019202020212022320232024120252026
  • Recalls (2)
  • Inspections (1)
  • Warning letters (1)

Devices registered here (1)

  • Indicator, Physical/Chemical Sterilization Process
    Product code JOJ (opens in a new tab) · Class II · General Hospital · 21 CFR 880.2800

Recalls & enforcement

  • Class IIOngoing2025-01-15
    Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
  • Class IIOngoing2023-12-07
    Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

FDA inspections (1)

  • OAI2023-06-09
    Official 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.

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. “TERRAGENE SA (FEI 3013145340) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013145340-terragene-sa/

Not open yet

Alerts for TERRAGENE SA

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.