BEUDAMED
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    HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code CCQ·October 10, 2014

    HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CCQ·October 10, 2014

    WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·June 1, 2011

    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 14, 2016

    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

    FDA Enforcement
    Class II ·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017

    NEUROMEND

    FDA Adverse Event
    Malfunction ·COLLAGEN MATRIX, INC.·Product code JXI·August 24, 2016

    CESPACE BONE CORT CAN 9X14X11.5MM LORDO

    FDA Adverse Event
    Malfunction ·CONTRACT MANUFACTURER: RTI SURGICAL·Product code JDN·May 27, 2016

    9710055-2008-00010

    FDA Adverse Event
    Other ·Product code FSY·September 5, 2008

    CESPACE BONE CORT CAN 10X16X13.5MM LORDO

    FDA Adverse Event
    Malfunction ·CONTRACT MANUFACTURER: RTI SURGICAL·Product code LMO·May 27, 2016

    Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·January 18, 2017

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·October 31, 2024

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·October 31, 2024

    UNKNOWN CLOSED SUCTION CATHETER

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BSY·July 19, 2019

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 16, 2015

    Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·December 27, 2017

    PHACOFLEX II

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQL·April 25, 2018

    MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·July 3, 2025

    AMBU BAG

    FDA Adverse Event
    Injury ·WESTMED, INC.·Product code BTM·July 10, 2006

    Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·December 27, 2017