Class IIOngoingZ-2088-2026
DFI Co., Ltd. recalls One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
All device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 601–612 of 4,586 recalls
Class IIOngoingZ-2087-2026
DFI Co., Ltd. recalls One Step K in vitro diagnostic test REF: 81A4
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Class IIOngoingZ-2086-2026
DFI Co., Ltd. recalls Uric Acid in vitro diagnostic test REF: 31H0P
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Class IIOngoingZ-2085-2026
DFI Co., Ltd. recalls QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
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
Class IIOngoingZ-2083-2026
DFI Co., Ltd. recalls One Step UTI in vitro diagnostic test REF: 3374
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Class IIOngoingZ-2082-2026
DFI Co., Ltd. recalls One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Class IIOngoingZ-2081-2026
BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Respiratory/sore throat panel test may result in false negative results and control failures.
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Under Investigation by firm
BioFire Diagnostics, L…UTMay 13, 2026
Class IIOngoingZ-2080-2026
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures.…
Katalyst Surgical, LLCMOMay 13, 2026
Class IIOngoingZ-2079-2026
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical, LLCMOMay 13, 2026
Class IIOngoingZ-2078-2026
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical, LLCMOMay 13, 2026
Class IIOngoingZ-2077-2026
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical, LLCMOMay 13, 2026