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    CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, catalog number 2002022; Material number: H30120020230 120 Channel CLEARSIGN II Amplifier, catalog number 2002023; Material number: H30120020240 160 Channel Clearsign II Amplifier, catalog number 2002014. The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LABSYSTEM PRO EP Recording System) that can record and display the information

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRQ·June 2, 2015

    Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; 4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S; 5) GOWN,SIRUS,NONRNF,XLN/XL,20/CS, Model Number: DYNJP2002SL; 6) GOWN,NONRNF,2XL,18/CS, Model Number: DYNJP2003; 7) GOWN,SIRUS,NONRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2003S; 8) GOWN,SIRUS,NONRNF,XLN/2XL,18/CS, Model Number: DYNJP2003SL; 9) GOWN,NONRNF,3XL,18/CS, Model Number: DYNJP2004; 10) GOWN,SIRUS,NONRNF,3XL,18/CS, Model Number: DYNJP2004S; 11) GOWN,NONRNF,SM,30/CS, Model Number: DYNJP2005; 12) GOWN,SIRUS,NONRNF,SM,30/CS, Model Number: DYNJP2005S; 13) GOWN,NONRNF,4XL,18/CS, Model Number: DYNJP2009; 14) GOWN,SIRUS,NONRNF,4XL,18/CS, Model Number: DYNJP2009S; 15) GOWN,ECLIPSE,FABRNF,L,30/CS, Model Number: DYNJP2101; 16) GOWN,SIRUS,FABRNF,L,20/CS, Model Number: DYNJP2101S; 17) GOWN,ECLIPSE,FABRNF,XL,30/CS, Model Number: DYNJP2102; 18) GOWN,SIRUS,FABRNF,XL,20/CS, Model Number: DYNJP2102S; 19) GOWN,ECLIPSE,FABRNF,2XL,18/CS, Model Number: DYNJP2103; 20) GOWN,SIRUS,FABRNF,2XL,18/CS, Model Number: DYNJP2103S; 21) GOWN,ECLIPSE,POLYRNF,L,30/CS, Model Number: DYNJP2201; 22) GOWN,SIRUS,POLYRNF,SETINSLV,L,20/CS, Model Number: DYNJP2201S; 23) GOWN,ECLIPSE,POLYRNF,XL,30/CS, Model Number: DYNJP2202; 24) GOWN,SIRUS,POLYRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2202S; 25) GOWN,ECLIPSE,POLYRNF,2XL,18/CS, Model Number: DYNJP2203; 26) GOWN,SIRUS,POLYRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2203S; 27) GOWN,ECLIPSE,POLYRNF,XLN/L,28/CS, Model Number: DYNJP2204; 28) GOWN,SIRUS,POLYRNF,XLN/LG,20/CS, Model Number: DYNJP2204S; 29) GOWN,ECLIPSE,POLYRNF,XLN/XL,28/CS, Model Number: DYNJP2205; 30) GOWN,SIRUS,POLYRNF,XLN/XL,20/CS, Model Number: DYNJP2205S; 31) GOWN,ECLIPSE,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206; 32) GOWN,SIRUS,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206S; 33) DBQ-GOWN,PREVENTION PLUS,LN/L,ST,24/CS, Model Number: DYNJP2301P; 34) DBQ-GOWN,PREVENTION PLUS,XLN/XL,ST,24/CS, Model Number: DYNJP2302P; 35) DBD-GOWN,PREVENTION PLUS,XLN/2XL,ST,22/C, Model Number: DYNJP2303P; 36) DBD-GOWN,PREVENTION PLUS,L,ST,24/CS, Model Number: DYNJP2306P; 37) DBQ-GOWN,PREVENTION PLUS,XL,ST,24/CS, Model Number: DYNJP2307P; 38) DBQ-GOWN,PREVENTION PLUS,2XL,ST,22/CS, Model Number: DYNJP2308P; 39) GOWN,ORBIS,LVL 3,LRG/XLONG,ST,24/CS, Model Number: DYNJP2361P; 40) GOWN,ORBIS,LVL 3,XLONG/XLARGE,ST,24/CS, Model Number: DYNJP2362P; 41) GOWN,ORBIS,LVL 3,XLNG/XXLARGE,ST,22/CS, Model Number: DYNJP2363P; 42) GOWN,ORBIS,LVL 3,LARGE,ST,24/CS, Model Number: DYNJP2366P; 43) GOWN,ORBIS,LVL 3,XLARGE,ST,24/CS, Model Number: DYNJP2367P; 44) GOWN,ORBIS,LVL 3,XXLARGE,ST,22/CS, Model Number: DYNJP2368P; 45) GOWN,ORBIS,LVL 3,4XL,ST,20/CS, Model Number: DYNJP2369P; 46) GOWN,SIRUS,NONRNF,RAGLAN,L,ST,32/CS, Model Number: DYNJP2401; 47) GOWN,SIRUS,NONRNF,RAGLAN,XL,ST,30/CS, Model Number: DYNJP2402; 48) GOWN,SIRUS,NONRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2403; 49) GOWN,SIRUS,FABRNF,RAGLAN,L,ST,30/CS, Model Number: DYNJP2501; 50) GOWN,SIRUS,FABRNF,RAGLAN,XL,ST,28/CS, Model Number: DYNJP2502; 51) GOWN,SIRUS,FABRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2503; 52

    FDA Recall
    Open, Classified ·Product code FYA·January 7, 2026

    Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL

    FDA Recall
    Open, Classified ·Product code FYA·January 28, 2026

    GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardioverter Defibrillator, Sterile Lot. Guidant Corporation, Hamline Avenue North, St Paul, MN 551124-6798. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·March 4, 2009

    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

    FDA Recall
    Open, Classified ·Drs Vascular, Inc·Product code KGS·May 16, 2025

    CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

    FDA Recall
    Terminated ·DRG International Inc·Product code JSO·November 9, 2009

    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CFP·October 7, 2024

    CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

    FDA Recall
    Terminated ·DRG International Inc·Product code JSO·November 9, 2009

    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code JLX·September 13, 2024

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    FDA Recall
    Terminated ·DRG International, Inc.·Product code JKD·December 21, 2021

    Total Thyroxine (T4) ELISA; REF EIA-1781

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code KLI·October 18, 2021

    Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CDZ·July 5, 2024

    Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CDX·June 4, 2025

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Recall
    Terminated ·Oscor, Inc.·Product code IKD·March 31, 2017

    Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code DAQ·December 17, 2018

    Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

    FDA Recall
    Open, Classified ·Changchun Wancheng Bio-Electron Co., Ltd. 2336, Tianwei Road Beihu Science and Technology Development Zone Changchun China·Product code DFQ·November 22, 2025

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Recall
    Open, Classified ·DRE Medical Group Inc·Product code MNT·May 15, 2023

    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

    FDA Recall
    Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code PEJ·July 14, 2016

    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    FDA Recall
    Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code CDZ·May 21, 2019

    DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic

    FDA Recall
    Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code JLS·June 6, 2019