BEUDAMED
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    Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. The pouch assembies are packaged in a five-pack product box.

    FDA Recall
    Terminated ·Symbiosis Corp.·Product code DQX·July 16, 2002

    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code LQC·January 4, 2021

    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code LQC·January 4, 2021

    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·April 1, 2019

    Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code FDI·May 3, 2010

    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEM·June 10, 2019

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019

    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·July 24, 2019

    MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEQ·September 11, 2015

    MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 14, 2015

    Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.

    FDA Recall
    Terminated ·Acumedia Manufacturers, Inc.·Product code JSJ·August 2, 2018

    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

    FDA Recall
    Terminated ·Engineered Medical Systems, Inc·Product code BSJ·September 12, 2011

    BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JSJ·June 6, 2013

    BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin is used for the selective isolation of fastidious and slow-growing, obligately anaerobic gram-negative bacteria from a variety of clinical and nonclinical materials.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JSJ·June 6, 2013

    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSJ·March 21, 2016

    BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JSJ·June 6, 2013

    Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION PACK-LF DYNJ64834 CARDIAC A & B SJ PACK DYNJ0619768D CARDIAC PROCEDURE PACK DYNJ63700 CLOSURE CDS CDS983704D CLOSURE CDS CDS983704F CLOSURE CDS CDS983704G COLECTOMY LAPAROSCOPIC DYNJ906875 COLORECTAL ME DYNJ906437 CRANIOTOMY DYNJ905330A CRANIOTOMY DYNJ905330B C-SECTION PACK DYNJ32884F C-SECTION PACK DYNJ32884G C-SECTION PACK DYNJ32884I C-SECTION PACK DYNJ32884J C-SECTION TRAY DYNJ62707 CYSTO DYNJ901329B CYSTO DYNJ901608B CYSTO DYNJ903225I CYSTO CDS982015O CYSTO DYNJ903225J CYSTO CDS982015P CYSTO DYNJ903225K CYSTO DYNJ906481 CYSTO DYNJ903225L CYSTO CDS CDS985376C CYSTO CDS-LF CDS982481I CYSTO CDS-LF CDS982481J CYSTO CDS-LF CDS982481K CYSTO CDS-LF CDS982481L CYSTO PACK DYNJ05177G CYSTO PACK DYNJ51350A CYSTO PACK DYNJ37252F CYSTO PACK DYNJV0052L CYSTO PACK DYNJ37680D CYSTO PACK DYNJ58223 CYSTO PACK DYNJ53570A CYSTO PACK CMPJ01845I CYSTO PACK DYNJ37252G CYSTO PACK DYNJ37252I CYSTO PACK-LF DYNJ24911D CYSTO PACK-LF CMPJ02168J CYSTO PACK-LF DYNJ30470B CYSTO PACK-LF CMPJ02168K CYSTO PACK-LF DYNJ51350B CYSTO PACK-LF DYNJ51350C CYSTO TRAY-LF DYNJ42146A CYSTO/UROLOGY PACK DYNJ64197 CYSTO-LF DYNJ50098 CYSTOSCOPY-LF DYNJ22891I D&C HYSTEROSCOPY DYNJ901049B D&C HYSTEROSCOPY DYNJ901049C D&C HYSTEROSCOPY DYNJ901049D D&C HYSTEROSCOPY PACK CMPJ43148C D&C HYSTEROSCOPY PACK CMPJ43148D D&C HYSTEROSCOPY PACK CMPJ43148F D&C PACK DYNJ33603D D&C PACK DYNJ22567C D&C PACK DYNJ22567D D&C PACK DYNJ55814B D&C PACK-LF DYNJ22567F D&C/GYN-LF DYNJ61949 D&C/GYN-LF DYNJ61949A D&C-LF DYNJ50099A D&C-LF DYNJ906482 DELIVERY PACK SMMC-LF DYNJ35244D DELIVERY PACK SMMC-LF DYNJ35244F DENTAL ENT PACK-LF DYNJ43405B DR H PACK DYNJ62374 DR. S PACK DYNJ60499 EAR DYNJ906058A EAR DYNJ906058B EAR DYNJ906058F GEN PLASTIC DYNJ901298A GENERAL DELIVERY PACK-LF DYNJ15915F GENERAL PACK DYNJ37894B GENERAL PACK DYNJ61784 G S CYSTO PACK DYNJ62403 G CYSTO CDS CDS984190G G CYSTO CDS CDS984190I G CYSTO CDS CDS984190J G D & C CDS CDS984203F G D & C CDS CDS984203G G D & C CDS CDS984203I G D & C CDS CDS984203J G LASER VEIN CDS CDS984193M G LASER VEIN CDS CDS984193N G PELVISCOPY CDS CDS984187M G PELVISCOPY CDS CDS984187N G PELVISCOPY CDS CDS984187O G PELVISCOPY CDS CDS984187P G VAGINAL CDS CDS984201M G VAGINAL CDS CDS984201O G VAGINAL CDS CDS984201P G VAGINAL CDS CDS984201Q GU SEED PACK-RF-LF DYNJ01631F GU-GEN ROBOTIC PACK CMPJ11121 GYN LAPAROSCOPY DYNJ903869 GYN LAPAROSCOPY DYNJ901636B GYN LAPAROSCOPY DYNJ902101A GYN LAPAROSCOPY DYNJ37256D GYN LAPAROSCOPY DYNJ903869A GYN LAPAROSCOPY DYNJ903869B GYN LAPAROSCOPY DYNJ903869C GYN LAPAROSCOPY DYNJ903869D GYN LAPAROSCOPY CDS CDS983410C GYN LAPAROSCOPY CDS CDS985217D GYN LAPAROSCOPY CDS CDS983410D GYN LAPAROSCOPY CDS CDS985217F GYN LAPAROSCOPY CDS CDS983410F GYN LAPAROSCOPY CDS CDS985217G GYN LAPAROSCOPY PACK DYNJ48614C GYN LAPAROSCOPY PACK DYNJ22568F GYN LAPAROSCOPY PACK DYNJ22568G GYN LAPAROSCOPY PACK DYNJ37337G GYN LAPAROSCOPY PACK-LF DYNJ22568I GYN LAPAROSCOPY/LAVH CDS CDS981294C GYN LITHOTOMY PACK DYNJ48615B GYN ONCOLOGY ME DYNJ900201G GYN ROBOTIC DYNJ903282D GYN ROBOTIC DYNJ903282F GYN ROBOTIC DYNJ903282G GYN ROBOTIC DYNJ903282I GYN ROBOTIC DYNJ903282J GYN ROBOTIC DYNJ903282L GYN-URO LAPAROSCOPY DYNJ904856 GYN-URO LAPAROSCOPY DYNJ904856A HEAD AND NECK PACK DYNJ46509C HEART PACK A&B CMPJ22236V HH PAIN CLINIC PACK DYNJ59488 HMT CY

    FDA Recall
    Terminated ·Medline Industries Inc·Product code LRO·March 9, 2020

    Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304.

    FDA Recall
    Terminated ·Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304·Product code IYE·March 30, 2005