BEUDAMED
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    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·August 25, 2021

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·November 23, 2003

    Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·December 30, 2020

    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

    FDA Enforcement
    Class II ·Terminated·InfuTronix LLC·July 31, 2019

    IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells; Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Kit EXT Enteric Bacterial Panel; Catalog # 443812

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Kit BD Max MRSA XT; Catalog # 443461

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code CHI·June 26, 2020

    Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code CHI·June 26, 2020

    Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code CHI·June 26, 2020

    Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GEH·September 22, 2020

    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OJH·January 21, 2020

    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8

    FDA Recall
    Terminated ·Globus Medical, Inc.·Product code MAX·July 22, 2020

    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15

    FDA Recall
    Terminated ·Globus Medical, Inc.·Product code MAX·July 22, 2020

    ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15

    FDA Recall
    Terminated ·Globus Medical, Inc.·Product code MAX·July 22, 2020

    ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15

    FDA Recall
    Terminated ·Globus Medical, Inc.·Product code MAX·July 22, 2020

    ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8

    FDA Recall
    Terminated ·Globus Medical, Inc.·Product code MAX·July 22, 2020

    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8

    FDA Recall
    Terminated ·Globus Medical, Inc.·Product code MAX·July 22, 2020