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    FlexLab X

    FDA UDI
    Inpeco SA·07640172344002·The FlexLab X automation is a modular system de...

    Vortex Surgical Inc

    FDA UDI
    Vortex Surgical, Inc.·00810123482443·25ga Kit (ILM Forceps, Flat Lens)

    FlexLab (FLX); Version: FLX-217-40;

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·December 3, 2025

    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

    FDA Enforcement
    Class II ·Ongoing·Vortex Surgical Inc.·February 11, 2026

    FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·October 15, 2025

    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code KDD·December 16, 2025

    S-ROM ZT TRIAL SLEEVE SIZE 24 F XX-LARGE

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code HWT·March 23, 2026

    HENRY SCHEIN

    FDA Adverse Event
    Malfunction ·A.R. MEDICOM INC. (SHANGHAI) LTD.·Product code FXX·December 12, 2016

    FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

    FDA Recall
    Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·September 3, 2025

    Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18 FX X-Coated Perfusion Pack Item Number: 72941 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    MASK, PROCEDURE, YELLOW

    FDA Adverse Event
    Injury ·QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.·Product code FXX·November 8, 2016

    3M

    FDA Adverse Event
    Injury ·3M·Product code FXX·January 23, 2012

    FACE MASK, EAR LOOP

    FDA Adverse Event
    Other ·CARDINAL HEALTH·Product code FXX·February 12, 2004

    1838R GLOBAL FILTRON SURGICAL MASK

    FDA Adverse Event
    Other ·3M HEALTH CARE·Product code FXX·February 1, 2010

    MASK SURG TIE SECURE BILL SECURE GARD

    FDA Adverse Event
    Other ·CARDINAL HEALTH·Product code FXX·February 9, 2010

    3M PARTICULATE RESPIRATOR AND SURGICAL MASK

    FDA Adverse Event
    Other ·3M HEALTH CARE·Product code FXX·April 30, 2010

    INSTA GARD YELLOW ISOLATION MASK

    FDA Adverse Event
    Other ·CARDINAL HEALTH·Product code FXX·April 21, 2010

    NEOTERIK

    FDA Adverse Event
    Malfunction ·NEOTERIK·Product code FXX·August 23, 1996

    ORGANIC VAPOR CHEMICAL CARTRIDGE

    FDA Adverse Event
    Malfunction ·SURVIVAIR·Product code FXX·July 18, 1996

    HEALTH CARE PARTICULATE RESPIRATOR MASK

    FDA Adverse Event
    Other ·3M CO.·Product code FXX·August 15, 1996