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.

RECALL: ETHILON. Suture, ETHIBOND. and MERSILENE. Polyester Fiber SUTURES and MERSILK. SUTURES, MULTIPLE LOTS1. Letter from MDB 2. Letter from Johnson & Johnson

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.

RECALL: Medtronic CoreValve Delivery System (DCS) Model:- DCS-C3-18FR or DCS-C4-18FR1. Letter from MDB 2. Letter from Medtronic

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.

RECALL: Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser1. Letter from MDB 2. Letter from Hospira

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.

RECALL: BD Microlance 30G x Needle by Becton Dickinson & Co.1. Letter from MDB

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.

RECALL: JOHNSON & JOHNSON 1•DAY ACUVUE® TRUEYETM BRAND CONTACT LENSES1. Letter from MDB 2. Letter from Johnson & Johnson

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/2008/008 - 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/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.

Recall : Voluntary Recall Of Durex Real Feel Batch1. Letter from MDB

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.

RECALL: Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion 1. Letter from MDB 2.  Reference

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.

RECALL: Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System.1. Letter from MDB 2. Letter from Arrow [Page 1 ] [Page 2 ]

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.

RECALL: Voluntary Recall of Clear & Simple Digital Pregnancy Test 1. Letter from MDB.

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/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.

ALERT: Fisher & Paykel Healthcare SleepStyle Series CPAP – Power Cord1. Letter from MDB 2. Letter from Fisher & Paykel 1 3. Letter from Fisher & Paykel 2 4. Letter from Fisher & Paykel3

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.

ALERT : Polydent Denture Adhesive Cream1. Letter from MDB 2. Letter from GlaxoSmithKline

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/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.

ALERT: All TomoTherapy Hi-ART Treatment Systems – operating on Version 4.0.0, 4.0.1 and 4.0.2 software1. Letter from MDB 2. TomoTherapy Notice 1 3. TomoTherapy Notice 2 4. TomoTherapy Notice 3 5. TomoTherapy Notice 4

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.

ALERT: Thoratec Heartmate II Left Ventricular Assist System (HM II LVAS) System Controllers1. Letter from MDB 2. Letter from THORATEC

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/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.