BEUDAMED
    96 results · 14ms · 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 ×

    Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 20MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 30MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 35MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device #7 PE Ziploop (TM) ToggleLoc (TM). Toggleloc anchors are indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.

    FDA Recall
    Terminated ·Biomet Sports Medicine·Product code MBI·April 24, 2008

    Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

    FDA Recall
    Open, Classified ·Noah Medical·Product code EOQ·March 9, 2024

    Galaxy System (GAL-001)

    FDA Recall
    Open, Classified ·Noah Medical·Product code EOQ·October 25, 2024

    Elecsys Troponin T; catalog number 2017644

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code MMI·April 25, 2003

    Elecsys Troponin T STAT; catalog number 2017423

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code MMI·April 25, 2003

    NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·June 1, 2022

    Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·October 9, 2018

    Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·October 9, 2018

    Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·October 9, 2018

    Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

    FDA Recall
    Open, Classified ·Noah Medical·Product code EOQ·October 28, 2024

    Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)

    FDA Recall
    Open, Classified ·Noah Medical·Product code EOQ·October 25, 2024

    Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal. Jug Herbal Scent NonSterile Model Number: 3565G

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code LRJ·May 25, 2022

    Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code LEA·April 29, 2015

    NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029

    FDA Recall
    Terminated ·Aribex Inc·Product code EHD·July 18, 2016

    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics, Inc.·Product code JIX·February 18, 2021

    Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.

    FDA Recall
    Open, Classified ·Noah Medical Corporation·Product code EOQ·September 12, 2025

    Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIRED LOT 183300, 1 SET, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE, P.O. BOX 587 WARSAW, IN 46581 USA EXPIRY DATE: 2021-03 Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JDC·April 29, 2011

    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017

    RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code MQM·December 30, 2014