Class IIOngoingZ-1950-2025
Tecfen Medical recalls Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife
Sterility assurance for Ophthalmic knives.
Tecfen MedicalCAJun 18, 2025
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 817–828 of 1,121 recalls
Class IIOngoingZ-1949-2025
Tecfen Medical recalls Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: Q…
Sterility assurance for Ophthalmic knives.
Tecfen MedicalCAJun 18, 2025
Class IIOngoingZ-1948-2025
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Mod…
It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
Ortho-Clinical Diagnos…NYJun 18, 2025
Class IIOngoingZ-1947-2025
Remel, Inc recalls Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Ly…
Product may have an off color affecting perfomance
Remel, IncKSJun 18, 2025
Class IIOngoingZ-1940-2025
Stryker GmbH recalls Femoral Nail
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Stryker GmbHJun 18, 2025
Class IIOngoingZ-1939-2025
Stryker GmbH recalls Femoral Nail
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Stryker GmbHJun 18, 2025
Class IIOngoingZ-1927-2025
QUANTUM SURGICAL SAS recalls EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user contr…
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
QUANTUM SURGICAL SASJun 18, 2025
Class IIOngoingZ-1923-2025
Olympus Corporation Of The Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fib…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Olympus Corporation of…PAJun 18, 2025
Class IIOngoingZ-1922-2025
Olympus Corporation Of The Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Olympus Corporation of…PAJun 18, 2025
Class IIOngoingZ-1921-2025
Olympus Corporation Of The Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulse…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Olympus Corporation of…PAJun 18, 2025
Class IIOngoingZ-1920-2025
Olympus Corporation Of The Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed La…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Olympus Corporation of…PAJun 18, 2025
Class IOngoingZ-1869-2025
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM LVP Blood Products Administration Set
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Fresenius Kabi USA, LL…MAJun 18, 2025