The FDA has posted 6 enforcement recalls of device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples devices since 2025, none of them Class I (most serious). Most recent report: Dec 10, 2025.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples”). Informational only — verify against the FDA before acting.