BEUDAMED
    20 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-BIO-65 - 1.3 m2 surface area, Model AM-BIO-75 - 1.5 m2 surface area and Model AM-BIO-100 - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co., Ltd·Product code MSE·October 12, 2006

    Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-BIO-75D - 1.5 m2 surface area and Model AM-BIO-100D - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co., Ltd·Product code MSE·October 12, 2006

    Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E,

    FDA Recall
    Open, Classified ·Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom·Product code DSY·December 18, 2025

    Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.

    FDA Recall
    Terminated ·Remel, Inc.·Product code JSI·February 21, 2007

    Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-7409 Explorer - Single End #7 SE. +H65810074090C. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).

    FDA Recall
    Terminated ·Hu-Friedy Mfg Co, Inc.·Product code EKB·January 7, 2005

    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

    BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LSE·November 13, 2007

    Epstein-Barr Virus (EBV VCA & EBNA IgG) Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code LSE·November 3, 2025

    BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D).

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LSE·November 13, 2007

    EBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    FDA Recall
    Terminated ·Calbiotech Inc·Product code LSE·August 27, 2008

    Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.

    FDA Recall
    Terminated ·Diamedix Corporation·Product code LSE·October 20, 2014

    Stryker Trio Mobile Surgery Platform; Model 1033.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FSE·May 15, 2006

    BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagent Pack***UNITED STATES, Bio-Rad Laboratories, Inc., Hercules, CA 94547". BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LSE·March 11, 2011

    DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LSE·November 1, 2004

    Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability

    FDA Recall
    Terminated ·Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304-1030·Product code IYE·February 4, 2005

    Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A; 8) CATARACT PACK WRO-LF, REF DYNJ41861; 9) EYE PACK, REF DYNJ43911; 10) PHACO PACK, REF DYNJ44748I; 11) DR DRUMMOND EYE PACK, REF DYNJ45344G; 12) OPHTHALMIC PACK, REF DYNJ47275A; 13) CATARACT PACK, REF DYNJ49412B; 14) CATARACT PACK, REF DYNJ50948A; 15) CATARACT PACK, REF DYNJ50948A; 16) CATARACT DR MALONE PACK, REF DYNJ51590A; 17) CATARACT DR MALONE PACK, REF DYNJ51590A; 18) CUSTOM EYE TRAY, REF DYNJ51821B; 19) EYE SURGERY PACK, REF DYNJ53097C; 20) CATARACT KIT, REF DYNJ53944; 21) EYE PACK, REF DYNJ54847D; 22) PK, OPHTH-EYE, REF DYNJ55070B; 23) EYE PACK, REF DYNJ55320D; 24) PK, OPHTH-RETINA, REF DYNJ59253B; 25) RETINA PACK, REF DYNJ60515; 26) ASED KIT, REF DYNJ60745D; 27) CATARACT PACK, REF DYNJ61321B; 28) EYE PACK, REF DYNJ61862A; 29) CATARACT PACK DR FREDERICK, REF DYNJ63163; 30) CATARACT DR ESTOPINAL, REF DYNJ63164; 31) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 32) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 33) HMSL EYE PACK, REF DYNJ64537A; 34) EYE PACK, REF DYNJ65271C; 35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832; 36) BASIC CATARACT PACK, REF DYNJ69165D; 37) BASIC CATARACT PACK, REF DYNJ69165D; 38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082; 39) CATARACT PACK WITH NO TUB, REF DYNJ80232; 40) RETINA PACK, REF DYNJ80483; 41) RETINA PACK, REF DYNJ81640; 42) WESTFALL OCCUPLASTY, REF DYNJ81796A; 43) EYE PACK, REF DYNJ83799C; 44) OPHTHALMIC PACK, REF DYNJ85275; 45) CATARACT, REF DYNJ908059A; 46) EYE TRAY 1-LF, REF LLSCAEYE01A; 47) PHACO PACK, REF LYN011PHNHD; 48) PHACO PACK, REF LYN011PHNHD; 49) SPECIALTY BESSER PACK, REF LYN023BPSSD; 50) SPECIALTY BESSER PACK, REF LYN023BPSSD; 51) SPECIALTY BESSER PACK, REF LYN023BPSSD; 52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 54) OPHTHALMIC PACK, REF LYN023OPSOB; 55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB; 56) BASIC CATARACT PACK, REF LYN030BCSDB; 57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA; 58) AIKEN CATARACT PACK II, REF LYN030CTAKG; 59) AIKEN CATARACT PACK II, REF LYN030CTAKG; 60) AIKEN CATARACT PACK II, REF LYN030CTAKG; 61) VA EYE II-LF, REF LYN030VAEYA; 62) VA EYE II-LF, REF LYN030VAEYA; 63) CATARACT PACK, REF LYN035CTSEC; 64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 66) OPHTHALMIC PACK, REF LYN041OPFCC; 67) OPHTHALMIC PACK, REF LYN041OPFCC; 68) OPHTHALMIC PACK, REF LYN041OPFCC; 69) OPHTHALMIC PACK, REF LYN041OPFCC; 70) CATARACT PACK, REF LYN042CPFEG; 71) OPTHALMIC PACK-LF, REF PHS529724000B; 72) CATARACT PACK, REF VAL001CPMEB; 73) CATARACT PACK, REF VAL001CPMEB; 74) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 75) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA; 77) CATARACT PACK, REF VAL009CAAHC; 78) RENAISSANCE CAT PACK, REF VAL009CAREA; 79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA; 80) CATARACT PACK, REF VAL009CTSGA; 81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC; 82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA; 83) RENAISSANCE VIT PACK, REF VAL009VIREA; 84) CATARACT PACK APERTURE, REF VAL011CTVAA; 85) OPHTHALMIC PACK, REF VAL022BSOMD; 86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD; 87) EYE PACK, REF VAL024EYTRB; 88) CATARACT PACK, REF VAL026CTNFC; 89) EYE PACK, REF VAL029EYGSB; 90) INTRAOCULAR PACK, REF VAL031IOGCB; 91) CATARACT, REF VAL035CPAEC; 92) CATARACT PACK 2, REF VAL036CABRD; 93) BRINTON VISION ICL PACK, REF VAL037ICBVG; 94) EYE PACK, REF VAL038BSCID; 95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB; 96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA; 97) BOOZMAN HOF PACK 2, REF VAL042EYBHC; 98) CATARACT PACK WILD

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJK·September 4, 2024

    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

    TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) #7692; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.

    FDA Recall
    Terminated ·Tenet Medical Engineering Inc 11979 40th St Se /#203 Ab Calgary Canada·Product code JEB·November 23, 2007

    TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.

    FDA Recall
    Terminated ·Tenet Medical Engineering Inc 11979 40th St Se /#203 Ab Calgary Canada·Product code JEB·November 23, 2007

    TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) #7693; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.

    FDA Recall
    Terminated ·Tenet Medical Engineering Inc 11979 40th St Se /#203 Ab Calgary Canada·Product code JEB·November 23, 2007