FDADecember 7, 2023device
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
What to do
FDA enforcement status: Ongoing
Brands named
terragene
UPCs
0779816467962207798164678656077981646793700036697505876807798164677888
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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