BEUDAMED
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    Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFG·February 11, 2025

    Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 5) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 6) PHLEBECTOMY PACK, Model Number: DYNJ55215G; 7) BIOPSY/DRAINAGE TRAY-LF, Model Number: DYNJ30078D; 8) CAT BIOPSY PACK, Model Number: DYNJ62968; 9) ABLATION/DRAINAGE PACK, Model Number: DYNJ53658D; 10) BIOPSY KIT, Model Number: DYNJ61130B

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFG·March 3, 2025

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B

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

    MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302

    FDA Recall
    Open, Classified ·Product code OFG·May 4, 2026

    Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·October 16, 2020

    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code ODG·April 6, 2016

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code ODG·May 23, 2017

    Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654

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

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·August 21, 2015

    Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·October 16, 2020

    Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Number 00-400832O ; 6) BIOPSY PROCEDURE PACK , Pack Number 00-400832P ; 7) BIOPSY PROCEDURE PACK , Pack Number 00-401261F ; 8) 6" FEMORAL ARTERIALLINE KIT, Pack Number ART245B; 9) BREAST BIOPSY KIT , Pack Number BT1085A; 10) BREAST BIOPSY PROCEDURE TRAY, Pack Number BX8375F; 11) BREAST/MINOR, Pack Number CDS980228X ; 12) BIOPSY CDS-LF , Pack Number CDS984667D ; 13) BIOPSY CDS-LF , Pack Number CDS984667F ; 14) BREAST-HERNIA-PORT CDS-LF , Pack Number CDS984853G ; 15) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 16) QSUM STEREO/US BIOPSY TRAY, Pack Number CT101; 17) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960; 18) BIOPSY DEKALB PACK, Pack Number DM150A ; 19) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 20) COLONOSCOPY KIT , Pack Number DYKE1218 ; 21) BREAST BIOPSY KIT , Pack Number DYNDA1224B ; 22) TDC REMOVAL, Pack Number DYNDA1633A; 23) BREAST BIOPSY PACK, Pack Number DYNDA2378A ; 24) CUSTOM BIOPSY TRAY, Pack Number DYNDA2448; 25) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 26) BIOPSY/MYELOGRAM PACK, Pack Number DYNDA2655; 27) PICU LINE TRAY, Pack Number DYNDC1960A; 28) PORT ACCESS KIT, Pack Number DYNDC2945; 29) CT BIOPSY TRAY, Pack Number DYNDH1054; 30) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 31) BIOPSY PACK , Pack Number DYNDH1110; 32) ARTHROGRAM TRAY, Pack Number DYNDH1113; 33) BIOPSY TRAY , Pack Number DYNDH1114; 34) BIOPSY TRAY, Pack Number DYNDH1129; 35) ARTHROGRAM TRAY, Pack Number DYNDH1134; 36) BIOPSY PACK , Pack Number DYNDH1137A ; 37) BREAST BIOPSY TRAY, Pack Number DYNDH1142C ; 38) BREAST BIOPSY TRAY, Pack Number DYNDH1152A ; 39) BIOPSY KIT, Pack Number DYNDH1156; 40) ULTRASOUND TRAY, Pack Number DYNDH1204; 41) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 42) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 43) CORE BIOPSY TRAY, Pack Number DYNDH1233; 44) BIOPSY PACK, Pack Number DYNDH1248; 45) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 46) BREAST BIOPSY TRAY, Pack Number DYNDH1266; 47) GENERAL BIOPSY TRAY , Pack Number DYNDH1268; 48) BIOPSY TRAY, Pack Number DYNDH1269; 49) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 50) DB CT BIOPSY TRAY -LF , Pack Number DYNDH1270; 51) BIOPSY TRAY , Pack Number DYNDH1273; 52) BIOPSY PACK TAA COMPLIANT , Pack Number DYNDH1294; 53) BREAST BIOPSY TRAY, Pack Number DYNDH1296B ; 54) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 55) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 56) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 57) BREAST BIOPSY TRAY, Pack Number DYNDH1302; 58) BREAST BIOPSY TRAY, Pack Number DYNDH1302H ; 59) BIOPSY TRAY, Pack Number DYNDH1314; 60) BIOPSY TRAY , Pack Number DYNDH1314A ; 61) MAMMOGRAPHY BREAST BIOPSY, Pack Number DYNDH1318; 62) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 63) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324; 64) BIOPSY TRAY, Pack Number DYNDH1328; 65) CT BIOPSY TRAY, Pack Number DYNDH1355A ; 66) BONE MARROW BIOPSY ASPIRATION , Pack Number DYNDH1376A ; 67) BREAST BIOPSY PACK, Pack Number DYNDH1425; 68) THYROID BIOPSY PACK , Pack Number DYNDH1430A ; 69) BONE MARROW BIOPSY KIT, Pack Number DYNDH1434; 70) SOFT TISSUE BIOPSY, Pack Number DYNDH1477; 71) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496A ; 72) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496AH; 73) BREAST BIOPSY , Pack Number DYNDH1518A ; 74) BIOPSY, Pack Number DYNDH1543; 75) BIOPSY PACK , Pack Number DYNDH1556; 76) BIOPSY PACK , Pack Number DYNDH1556D ; 77) IR BIOPSY TRAY, Pack Number DYNDH1569; 78) BIOPSY KIT, Pack Number DYNDH1570; 79) STEREOTACTIC BIOPSY , Pack Number DYNDH1572; 80) ULTRASOUND BIOPSY , Pack Number DYNDH1573A ; 81) BREAST BIOPSY , Pack Number DYNDH1575; 82) CT BIOP

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

    Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512A

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

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.

    FDA Recall
    Open, Classified ·Product code OFG·March 19, 2026

    Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A

    FDA Recall
    Open, Classified ·Product code OFG·February 25, 2026

    Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief

    FDA classification
    FDA Class 2 ·Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief