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    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

    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

    Proclaim DRG Implantable Pulse Generator, Model Number 3664

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code PMP·March 9, 2018

    Proclaim DRG Implantable Pulse Generator Model 3664

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code LGW·September 12, 2017

    Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP-US-Z -10 (10cc Kit) Product Usage: Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects

    FDA Recall
    Terminated ·Doctor's Research Group, Inc.·Product code GXP·April 6, 2012

    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

    Kits and Trays containing alcohol swabstick/prep pad: GEO-MED BIOPSY TRAY, V A MED CTR MARTINSBURG, REF 89-7617.01 Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) ST TPN/CVC DRG KIT W/VAD, REF 47-003, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TPN/CVC Dressing Change Kit, REF 47-094.019, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TPN/CVC DRG CHG KIT, REF 47-276.13, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST CEN LINE KIT, REF 47-324, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST PED TRAY, REF 47-327, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST MAYO CLINIC PICC KIT, REF 47-483, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST PICC DRG CHG KIT, REF 47-491.12, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST IHC DRG CHG KIT, REF 47-600, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, Made in the Dominican Republic; DeRoyal (R) PRESBYT PIC KIT-NICU, REF 47-626.10, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST NEONATAL DRG CHG KIT, REF 47-670.05, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW PREP TRAY, UNIV OF ROCHESTER, REF 47-743.01, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) St. Central Line Kit, REF 47-777.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ARTERIAL LINE HYPER TRAY-25C, UNIV VIRGINIA CHARLOTTESVILLE, REF 50-3474.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW BIOPSY, UNIVERSITY OF WASHINGTON, REF 89-3899.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BIOPSY TRAY, PARKWAY RADIOLOGY, REF 89-6306.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ARTERIAL LINE TRAY, ERLANGER MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST DRESSING CHANGE KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST DIALYSIS KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TRN/CVC DRG KIT W/TRANS, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CVC Dressing Change Kit, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code LRP·February 7, 2011

    Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PMP·May 16, 2024

    Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·July 18, 2023

    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702

    FDA Recall
    Open, Classified ·Product code FTN·February 27, 2026

    Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.

    FDA Recall
    Open, Classified ·Product code OXQ·December 12, 2025

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

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

    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

    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

    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

    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

    Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·July 18, 2023