BEUDAMED
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    VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code GRP·August 12, 2018

    Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code HIB·June 11, 2025

    HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code HIB·June 11, 2025

    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HIB·April 13, 2015

    Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code HIB·June 11, 2025

    Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code HIB·October 2, 2015

    BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

    FDA Recall
    Terminated ·Numed Inc·Product code NVM·April 21, 2025

    VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.

    FDA Recall
    Terminated ·DJO, LLC·Product code JOW·May 28, 2013

    Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B

    FDA Recall
    Open, Classified ·Product code OEZ·April 27, 2026

    Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CHRISTUS CH PEDIATRIC BASIC DYNJ61167G CVC INSERTION BUNDLE CVI3940A DAVINCI PACK SURGICOUNT DYNJ45544F EPCH BASIC PACK DYNJ83094C GENERAL PACK DYNJ39682B DYNJ84882 GENERAL RFD DYNJ906336F GENERAL SURGERY PACK DYNJT6003 GV MACD PACK DYNJ46952M IMPLANT PACK - BBI AR DYNJ63508A KIT THORACOSCOPY DYNJ908872F LVAD TRAY DM1120A MAJOR UROLOGY PACK-LF DYNJ0368525M MICRODISECT DECOMPRESS-LF DYNJ911467 MINOR PACK DYNJ86972 MULTI PURPOSE PACK DYNJ58406B OPEN HEART DYNJ903245C P&K PACK DYNJT5838 PACK,PEDIATRIC MAJOR DYNJ906888F PCNL DYNJ904468C PEDIATRIC MINOR RFD DYNJ906296I PEDIATRIC PACK DYNJ54239K PEDIATRIC SURGERY DYNJ81474B PERLMUTTER PACK DYNJT7387 RFT ISC NOBLES MINOR PACK DYNJ43954B ROBOTICS FMOL LADY OF THE LAKE DYNJ89584 ROBOTICS PACK DYNJ83622B SCOLI PACK NTX DYNJ68415C SMALL ABDOMINAL PACK-LF PHS41749G STIM IMPLANT TRIALS DYNJ87790A SUPPLEMENTAL PACK DYNJ65244 TENEX PACK DYNDH2190 THORACIC PACK DYNJ56616G THORACIC PACK SHD DYNJ68416C THORACOSCOPY DYNJ9425843R THORACOTOMY PM DYNJ906815A THORACOTOMY THORACOSCOPY DYNJ902882D TRAY,NEONATAL PICC DRSG CHANGE DYNDC1533B UNIVERSAL-ASC DYNJ900071C

    FDA Recall
    Open, Classified ·Product code LRO·April 27, 2026

    GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285. Indicated for the quantitative determination of plasma renin activity (PRA) by the radioimmunoassay of generated angiotension I.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code CIB·October 12, 2009

    Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011

    Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.

    FDA Recall
    Open, Classified ·Arthrex, Inc.·Product code HAB·August 27, 2018

    Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and Accessories.

    FDA Recall
    Terminated ·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008

    Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CIB·January 20, 2012

    Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011