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  • Device 13259
  • Manufacturer 13259
  • Event 13553
  • Implant 0
Recall of CREST SPIN BRUSH PRO WHITENING
  • Type of Event
    Recall
  • Event ID
    14871
  • Event Risk Class
    II
  • Event Initiated Date
    2004-11-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The reason for the product recall is procter & gamble have identified a quality issue affecting the crest spinbrush pro whitening brushes and replacement heads. the oscillating head may become detached.
Recall of LEGEND PLUS UNIPOLAR/BIPOLAR DUAL SENSOR SINGLE CHAMBER PACEMAKER (ACT. &..
  • Type of Event
    Recall
  • Event ID
    14873
  • Event Risk Class
    II
  • Event Initiated Date
    1996-04-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
Recall of TNT BLUE DISPOSABLE
  • Type of Event
    Recall
  • Event ID
    16380
  • Event Risk Class
    II
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Err:509.
Recall of AXSYM TROPONIN-I REAGENT PACK
  • Type of Event
    Recall
  • Event ID
    14991
  • Event Risk Class
    III
  • Event Initiated Date
    1999-10-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Calibration failures caused by error code 1027 "calibration check failure cal f/a ratio too small".
Recall of AXIOM ICONOS R200 FLUOROSCOPIC X-RAY SYSTEM
  • Type of Event
    Recall
  • Event ID
    14992
  • Event Risk Class
    II
  • Event Initiated Date
    2002-11-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The mounting screws of the tomographoc rod could possibily break. the deadline to complete this modification is december 27 2002.
Recall of ALCYON HDL
  • Type of Event
    Recall
  • Event ID
    14994
  • Event Risk Class
    III
  • Event Initiated Date
    2000-12-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The firm has determined that some lipemic specimens may produce depressed (or lower) hdl-chloresterol results.
Recall of ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT
  • Type of Event
    Recall
  • Event ID
    14880
  • Event Risk Class
    III
  • Event Initiated Date
    2010-03-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Customer safety advisory notice to notify affected customers of a software error on all acuson s2000 systems. respective clips zoomed cannot be accurately measured in the exam review or off the system on a workstation.
Recall of TRACHEOSTOMY TUBES CUFFLESS WIRE REINFORCED SILICONE ADJUSTABLE HYPERFLEX
  • Type of Event
    Recall
  • Event ID
    15029
  • Event Risk Class
    III
  • Event Initiated Date
    2001-07-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    On of the trays was sealed with nothing inside.
Recall of TA*60 SINGLE USE RELOADABLE STAPLER
  • Type of Event
    Recall
  • Event ID
    14881
  • Event Risk Class
    II
  • Event Initiated Date
    2004-05-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Some lots of ta single use staplers could cause the device to clamp and fire without the staples formed into tissue.
Recall of DRILL BIT
  • Type of Event
    Recall
  • Event ID
    14891
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The etching on the drill stop does not match the actual length. specifically the 6mm stop drill bit (03.505.051) had the #4 etched on them the 8mm stop drill bit stops (03.505.054) had the #6 on them and the 12mm drill bits (03.505.057) had the #10 etched on them.
Recall of LATEX EXAMINATION GLOVES
  • Type of Event
    Recall
  • Event ID
    28493
  • Event Risk Class
    III
  • Event Initiated Date
    1997-04-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
Recall of THERMASPLINT KITS (COMES IN SMALL MEDIUM AND LARGE)
  • Type of Event
    Recall
  • Event ID
    14975
  • Event Risk Class
    II
  • Event Initiated Date
    2011-03-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The alcohol prep pads contained in the kits may be contaminated with bacillus cereus.
Recall of LEICA BOND UNIVERSAL COVERTILES
  • Type of Event
    Recall
  • Event ID
    14687
  • Event Risk Class
    III
  • Event Initiated Date
    2014-11-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The outside barcode label may contain a lot number that does not match the lot number on the product label. the inner packaging has not been affected and contains the correct identifying lot number. the incorrect outer packaging label does not affect the form fit or function of the product.
Recall of S2 SCREWS LOCKING SCREW FULLY THREADED NON STERILE
  • Type of Event
    Recall
  • Event ID
    14689
  • Event Risk Class
    III
  • Event Initiated Date
    2005-10-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Blister package may damage during shipment.
Recall of OASIS POWER WHEELCHAIR
  • Type of Event
    Recall
  • Event ID
    14691
  • Event Risk Class
    III
  • Event Initiated Date
    2007-11-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Lot de moteurs defectueux. la defectuosite se constate par la perte de graisse au niveau du reducteur de vitesse.
Recall of FOCAL SOFTWARE CD
  • Type of Event
    Recall
  • Event ID
    14702
  • Event Risk Class
    II
  • Event Initiated Date
    2010-05-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    When reviewing xio plans created in relative dose mode in focal plan review the isodose distr. is displayed incorrectly. user may misinterpret actual dose delivered if plan is based only on the isodose display.
Recall of XVI (X-RAY VOLUME IMAGING SYSTEM)
  • Type of Event
    Recall
  • Event ID
    14983
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The joint between the drive gear and the gantry base drive wheel has become loose leading to fatigue failure of the securing bolts.
Recall of APILUX 2G
  • Type of Event
    Recall
  • Event ID
    15040
  • Event Risk Class
    II
  • Event Initiated Date
    2012-07-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The apilux 2g does not have a device licence to be autorized for the sale into canada.
Recall of XVI (X-RAY VOLUME IMAGING SYSTEM)
  • Type of Event
    Recall
  • Event ID
    14984
  • Event Risk Class
    II
  • Event Initiated Date
    2010-09-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Risk of mistreating patients was identified when the synergy xvi system is in the synergistiq configuration. the system guides the user into performing a couch move twice so that the patient could be treated in the incorrect position.
Recall of LASER LOUPES
  • Type of Event
    Recall
  • Event ID
    15217
  • Event Risk Class
    II
  • Event Initiated Date
    2012-04-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Through an internal finding it was discovered that the ink used to mark the laser loupes with the laser frequency it protects against may not permanently adhere to the device.
Recall of MILLENNIUM MG SYSTEM - MAIN SYSTEM
  • Type of Event
    Recall
  • Event ID
    16384
  • Event Risk Class
    II
  • Event Initiated Date
    2000-12-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Unwanted detector motion.
Recall of ECLIPSE
  • Type of Event
    Recall
  • Event ID
    15791
  • Event Risk Class
    II
  • Event Initiated Date
    2003-09-15
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Anomaly regarding eclipse dose calculation. dk.
Recall of 3M ACTIVE STRIPS (BRIGHTS)
  • Type of Event
    Recall
  • Event ID
    52242
  • Event Risk Class
    II
  • Event Initiated Date
    1998-03-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
Recall of IMMULITE 2000 SYSTEM - ANALYZER (CLASS 2)
  • Type of Event
    Recall
  • Event ID
    15340
  • Event Risk Class
    III
  • Event Initiated Date
    2006-09-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    In the tube transport chain sensor used to move a reaction tube within the immulite 2000 a false trigger can occur due to particulate contamination or dust.
Recall of OPUS CK-MB AND TOTAL CK CALIBRATORS
  • Type of Event
    Recall
  • Event ID
    15346
  • Event Risk Class
    III
  • Event Initiated Date
    1999-12-20
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Level a calibrator signals may be high for some vials. recovery of qc or patient results between the a and b level calibrator (0-2 ng/ml) of the curve would be low.
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About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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