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    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

    FDA Recall
    Terminated ·Cook Inc.·Product code MQG·January 12, 2018

    Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.

    FDA Recall
    Terminated ·Cook Inc.·Product code MQG·March 22, 2018

    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

    FDA Recall
    Terminated ·Cook Inc.·Product code MQG·January 12, 2018

    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQG·August 12, 2022

    Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.

    FDA Recall
    Terminated ·Cook Inc.·Product code MQG·March 22, 2018

    Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MQG·September 5, 2019

    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQG·August 12, 2022

    MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429

    FDA Recall
    Open, Classified ·Cook Medical Llc·Product code MQG·December 7, 2023

    Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707

    FDA Recall
    Terminated ·Cook Medical Llc·Product code MQG·December 16, 2020

    TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·April 6, 2012

    Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG

    FDA Recall
    Open, Classified ·Invacare Corporation·Product code ITI·November 12, 2021

    Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLASTICS, Pack Number CDS980200AA; 5) PLASTICS, Pack Number CDS980200Y ; 6) BREAST/MINOR, Pack Number CDS980228W ; 7) PLASTIC CDS , Pack Number CDS980232U ; 8) PLASTIC CDS , Pack Number CDS980232V ; 9) PLASTIC CDS , Pack Number CDS980232W ; 10) PLASTIC CDS , Pack Number CDS980232X ; 11) LTP CDS-LF, Pack Number CDS980375L ; 12) PLASTIC CDS , Pack Number CDS980457R ; 13) PLASTIC CDS , Pack Number CDS980457S ; 14) PLASTIC CDS , Pack Number CDS980457T ; 15) BREAST AUG, Pack Number CDS980567R ; 16) BREAST AUG, Pack Number CDS980567S ; 17) LARGE PROCEDURE-LF, Pack Number CDS981257J ; 18) LARGE PROCEDURE-LF, Pack Number CDS981257K ; 19) BREAST CDS, Pack Number CDS981691N ; 20) MAJOR PLASTICS CDS, Pack Number CDS981958I ; 21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ; 22) MINOR PLASTIC , Pack Number CDS982018K ; 23) MAJOR BREAST, Pack Number CDS982038S ; 24) VASAL RECONSTRUCTION, Pack Number CDS982042O ; 25) MINOR BREAST, Pack Number CDS982053M ; 26) MINOR BREAST, Pack Number CDS982053N ; 27) MINOR BREAST, Pack Number CDS982053O ; 28) MINOR BREAST, Pack Number CDS982053P ; 29) BREAST AUGMENTATION , Pack Number CDS982254K ; 30) BREAST AUGMENTATION , Pack Number CDS982254L ; 31) BREAST AUGMENTATION , Pack Number CDS982254M ; 32) BREAST REDUCTION CDS, Pack Number CDS982255G ; 33) BREAST REDUCTION CDS, Pack Number CDS982255I ; 34) BREAST REDUCTION, Pack Number CDS982255J ; 35) TYMPANOPLASTY , Pack Number CDS982720M ; 36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ; 37) REDUCTION CDS , Pack Number CDS982776J ; 38) REDUCTION CDS , Pack Number CDS982776K ; 39) REDUCTION CDS , Pack Number CDS982776L ; 40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ; 41) MAG PLASTIC CDS , Pack Number CDS982909I ; 42) MAG PLASTIC CDS , Pack Number CDS982909J ; 43) MAG PLASTIC CDS , Pack Number CDS982909K ; 44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ; 45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ; 46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ; 47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ; 48) GENERAL BREAST, Pack Number CDS983058G ; 49) GENERAL BREAST, Pack Number CDS983058I ; 50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ; 51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ; 52) BREAST CDS, Pack Number CDS983148A ; 53) BREAST CDS, Pack Number CDS983148B ; 54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ; 55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ; 56) MAJOR CDS , Pack Number CDS983292D ; 57) PECTUS REPAIR , Pack Number CDS983353R ; 58) PECTUS REPAIR , Pack Number CDS983353S ; 59) PECTUS REPAIR , Pack Number CDS983353T ; 60) PECTUS REPAIR , Pack Number CDS983353U ; 61) PECTUS REPAIR , Pack Number CDS983353V ; 62) PECTUS REPAIR , Pack Number CDS983353X ; 63) MAMMOPLASTY-LF, Pack Number CDS983478J ; 64) MAMMOPLASTY-LF, Pack Number CDS983478K ; 65) MAMMOPLASTY-LF, Pack Number CDS983478L ; 66) PLASTICS FREE FLAP, Pack Number CDS983493L; 67) PLASTICS FREE FLAP, Pack Number CDS983493M; 68) PLASTIC TORSO-LF, Pack Number CDS983496I ; 69) PLASTIC TORSO-LF, Pack Number CDS983496J ; 70) PLASTIC TORSO-LF, Pack Number CDS983496K ; 71) PLASTIC TORSO-LF, Pack Number CDS983496L ; 72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ; 73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ; 74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ; 75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ; 76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ; 77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ; 78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ; 79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ; 80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ; 81) NE BREAST RECON CDS , Pack Number CDS983660D ; 82) NE BREAST RECON

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FTN·April 8, 2024

    G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HKS·June 30, 2008

    Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·September 15, 2009

    Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray. Lioresal drug ampules contained witin Medtronic Lot N0016487 bear the primary manufacturer''s label and lot number 007J2583. The drug box is labeled with Lot 017H1925. Medtronic packages a manufacturer''s labeled ampule into a protective drug box. A lot number and drug lot expiration date are printed on the outside of the drug box. The filled and labeled drug box is placed inside a larger kit assembly that contains other components necessary to complete a pump refill. Only the large kit assembly (''Lioresal Refill Kit'') will display the Medtronic lot number (N0016487). The Model 8561 refill kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump infusion, implanted, programmable under product code LKK.

    FDA Recall
    Terminated ·Medtronic Inc, Neurological & Spinal Division·Product code LKK·November 19, 2004

    TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By: Invacare Corporation, Elyria, OH 44035 The Invacare TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-folding type power wheelchair, with mid wheel drive capability.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·February 10, 2012

    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

    FDA Recall
    Terminated ·Mermaid Medical A/S Frydensbergvej 25 Stenl?se Denmark·Product code DWO·June 15, 2015

    Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates

    FDA Recall
    Terminated ·Pml Microbiologicals Inc.·Product code JSO·August 17, 2007

    Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

    FDA Recall
    Open, Classified ·Invacare Corporation·Product code ITI·March 30, 2022

    Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174

    FDA Recall
    Terminated ·Pml Microbiologicals Inc.·Product code JSO·April 23, 2007