Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/002 - H-1200 Fast Fluid Warmer with integrated Air Detector/Clamp and H-31B and H-30 Air Detector/Clamp Accessory.   The risk of air embolism if the power of the fluid warmer unit is interrupted either manually or through power failure during an air detection event.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/003 - Frazier and Poole Suction Instruments used in surgery, manufactured by ConMed Corporation, are single-use device used during surgery for evacuating fluid, blood and debris.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/004 - Clinitest hCG Cassette Pregnancy test.   The test kit is intended for professional use only in hospitals/clinics and is not sold in pharmacies for home use.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/005 - IntraStent Unmounted Balloon Expandable Stent.  The manufacturer has advised the Irish Medicines Board of a recall of specific lots of the IntraSrent Unmounted Balloon Expandable Stent.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/001 - Implantable Cardioverter Defibrillator (ICD) lead.  Sprint Fidelis manufactured by Medtronic.   ICD lead recall due to risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss of pacing output, caused by fracture of the lead conductor.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/002 - Invasive blood pressure monitoring sets : LogiCal, NovaTrans and TranStar models with trigger flush device, manufactured by Smiths Medical.  Manufactured from October 2007 to Februsry 2008 inclusive.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/001 - Hospira butterfly winged needle infusion set  -  regular and intermittent.  All batches manufactured prior to April 2008. Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/006 - Surgical Blades manufactured by ConMed Linvatec Hall, in blister packaging - single use device.  Holes have been discovered in the corners of the blister packaging for these devices.  This may compromise the sterility of the device and lead to the possibility of infection.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/008 - Robertshaw endotracheal tubes (PVC, disposable) all sizes - manufactured by Phoenix Medical, a P3 Medical Ltd company.  Due to a manufacturing defect there is a risk of damage to the intubating stylet on its removal from the endotracheal tube. Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/003 - Homechoice / Homechoice Pro Automated Peritoneal Dialysis System - current software versions by Baxter Internationals.  The company has received a report of dehydration occurring in a pediatric patient, where patient received incorrect amount of dextrose (with different concentration).Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/004 - Lifepak 12 and Lifepak 20/20e Defibrillators/Monitors by Medtronics.  Field corrective action due to some of the above models have a potential to incorrectly render a shock or no shock decision during automated external defibrillators (AED) analysis.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/005 - Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TransStar models with trigger flush device.  These devices are disposable blood pressure monitoring sets with a trigger flush device to maintain patency of the line during invasive pressure monitoring.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/007 - Contaminated Heparin used in Carmeda Coatings Applied to selected cardiopulmonary bypass products manufactured by Medtronics.  Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/006 - Reports received from users stating that the Sterrad Sterilisers emitting a mist due to a premature mechanical failure in its oil mist filter and/or filter assemblies.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/009  -  Small number of SynchroMed II infusion pumps may have been manufactured without propellant, according to report.  8 SynchroMed II pump have been returned to Medtronic and confirmed to have a missing propellant.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/010  -  A limited number of electrosurgical blades and needles may have an inadequate packaging seal, potentially compromising the sterility of the device.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/007 -  Gambro has identified the potential for a total or partial occlusion of the arterial (red) and/or venous (blue) dialyser connectors of these blood tubing sets.   This is due to a moulding defect.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/008  -  Baxter Colleague Triple Channel Mono, CX and CXE Volumetric Infusion Pumps - upgrading of software.  Users of the abovementioned device should contact the distributor/supplier of this device.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/009  -  Procedure packs from various manufacturers which contain BD Medical Surgical Syatems 2ml, 5ml, and 10ml Plastipak Luer Slip syringes.  Potential for the BD Luer slip syringes supplied in procedure packs to spontaneously disconnect or fail to maintain a secure connection to Luer fittings of other devices.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/010  -  Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe pumps.  Possibility of patients being given an additional / unnecessary infusion when syringes are changed or infusion restarted when using DrugPro software.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/011  -  Mislabelling of device may result in the use of a fenestrated suction tube, reducing both suction and ventilation.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/011  -  Maximo II ICD, DR ICD and CRT-D by Medtronics.  The company is notifying customers that some of the above mentioned models have a configuration issue.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/012  -  Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles.  Use of the Valleylab Force FX-C or Valleylab SSE2L with the CentriMag Blood Pumping System may result in stoppage of the pump and may cause serious injury or death.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/A/2008/012  -  Prostiva RF Model 8929 Hand Piece Device - field corrective action letter dated 4 August 2008 from Medtronic International Ltd.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.

MDB/R/2008/013  -  All lots of Cordis LuMend Outback Ltd Re-entry Catheter - catalog number OTB42120.  Cordis has recently determined that the separation rate of the cannula to the deployment slide of the handle assembly of the catheter is higher than anticipated.Read more.