BEUDAMED
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    FGA 330 PORTABLE ALUMINUM LIFT 330 LBS

    FDA Adverse Event
    Malfunction ·PRISM MEDICAL·Product code FSA·October 11, 2015

    FGA 450

    FDA Adverse Event
    Malfunction ·HANDICARE USA·Product code FSA·March 23, 2018

    FGA 450 / 3-ALUMINUM LIFT 450 LB MEDIUM HEIGHT

    FDA Adverse Event
    Malfunction ·PRISM MEDICAL·Product code FSA·August 12, 2015

    FGA 450

    FDA Adverse Event
    Malfunction ·PRISM MEDICAL·Product code FSA·June 28, 2017

    UNKNOWN KNEE CONSTRUCT SIGMA

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 3, 2024

    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

    FDA Enforcement
    Class II ·Ongoing·Hycor Biomedical Inc·August 14, 2019

    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

    FDA Recall
    Open, Classified ·Hycor Biomedical Inc·Product code DHR·March 19, 2018

    QUANTUM2000 ELECTROSURG.

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·April 10, 2019

    PROLENE BLU 60CM M0.4

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAW·September 22, 2023

    CAMINO ICP MONITORING CATHETER W/ INTEGRATED LIC

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES CA/USA·Product code GWM·April 18, 2016

    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Completed·Hycor Biomedical Inc·August 7, 2019

    PE DRY/WET DUAL COLL LF 6/CS

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code KDQ·June 9, 2022

    PE ADULT-PED WET LF 6/CS

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code KDQ·December 16, 2019

    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.

    FDA Recall
    Completed ·Hycor Biomedical Inc·Product code DHR·February 21, 2018

    OP-TELESCOPE, 30°, 4 MM CHANNEL

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FGA·September 24, 2024

    OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FGA·February 10, 2023

    OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FGA·September 6, 2024

    FORCEPS

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code FGA·December 19, 2025

    HOPKINS TELESCOPE 6°, 18 FR.

    FDA Adverse Event
    Malfunction ·KARL STORZ SE & CO. KG·Product code FGA·October 30, 2025

    HOPKINS TELESCOPE 6°, 18 FR.

    FDA Adverse Event
    Malfunction ·KARL STORZ SE & CO. KG·Product code FGA·November 26, 2025