Class IIOngoingZ-2332-2026
HF Acquisition Co LLC recalls Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE
Due to incorrect incubation process being performed on product.
HF Acquisition Co LLCWAJun 17, 2026
Indicator, Biological Sterilization Process recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–4 of 4 recalls
Class IIOngoingZ-2331-2026
HF Acquisition Co LLC recalls Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE
Due to incorrect incubation process being performed on product.
HF Acquisition Co LLCWAJun 17, 2026
Class IIOngoingZ-1248-2025
TERRAGENE S.A. recalls ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
TERRAGENE S.A.Mar 5, 2025
Class IIOngoingZ-1141-2025
HF Acquisition Co LLC recalls Biological
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer'…
HF Acquisition Co LLCWAFeb 19, 2025