BEUDAMED
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    VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

    FDA Adverse Event
    Malfunction ·LIFECORE BIOMEDICAL, LLC·Product code LZP·December 10, 2024

    TRIAGE 8 PANEL FOR DRUGS OF ABUSE

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·August 25, 2015

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 1, 2022

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LFG·January 25, 2012

    *

    FDA Adverse Event
    Malfunction ·ZIMMER PATIENT CARE·Product code LFG·September 15, 2000

    ZIMMER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC. PATIENT CARE DIV.·Product code LFG·August 25, 2000

    MULTI-DRUG ONE STEP MULTI-LINE 11 DRUG SCREEN TEST DEVICE (URINE)

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code LFG·December 2, 2020

    MULTI-DRUG ONE STEP SCREEN TEST PANEL (URINE)

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code LFG·April 1, 2024

    BIOFLEX TESIO CATHETER

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code LFG·April 24, 2006

    BIOFLEX TESIO CATHETER

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code LFG·April 24, 2006

    SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code LFG·June 13, 2017

    ARROW AM/AT PI MIDLINE 2-L FG: 5.5FR X 15CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code FOZ·June 28, 2022

    PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

    FDA Enforcement
    Class III ·Terminated·Laurimed LLC·May 7, 2014

    Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I, i. DYNJ21244N, j. DYNJ46530J

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP SPT·Product code OJG·June 6, 2022

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OKV·November 17, 2022