Class IIOngoingZ-2084-2026
DFI Co., Ltd. recalls One Step pH in vitro diagnostic test REF: 31I4P
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Dye-Indicator, Ph (Urinary, Non-Quantitative) recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–4 of 4 recalls
Class IIOngoingZ-1264-2026
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo pH Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers;…
Changchun Wancheng Bio…Feb 11, 2026
Class IIOngoingZ-0767-2026
GET TESTED INTERNATIONAL AB recalls Organic Acids Profile Test Large
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0755-2026
GET TESTED INTERNATIONAL AB recalls Vaginal PH Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025