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: EPICARDIAL LEAD MODELS 5071, 4965, 4968 STERILE TRAY 1. 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.

RECALL: Advanced Bionics HiRes 90K Cochlear Implants (Model Number CI-1400-01 and CI-1400-02H)1. Letter from MDB 2. Letter from Advance Bionics 1 3. Letter from Advance Bionics 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.

RECALLS: Voluntary Recall of Limited Number of ACUVUE® Brand Contact Lenses 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/2008/002 - 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.

RECALL: RESPIRONICS TRILOGY 100 VENTILATORS 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/2008/012  -  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/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.

RECALL: Various Medical Devices Bearing COOK brand name1. Letter from MDB 2. Cook Inc. 3. Letter from MDB (Updated)

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: DBP-2800 Battery Packs used in its Lifeline AED and ReviveR AED (semi-automatic external defibrillators)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: Endopath ETS Compact Flex 45mm Articulating Linear Cutter1. Letter from MDB 2. Endopath Regulator Letter

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: IKARIA INOMAXDS DRUG DELIVERY SYSTEM, MODEL: 100031. Letter from MDB 2. US FDA Recall Link   3. Recall Letter

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/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/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/2008/013  -  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.

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: MULTIPLE LOTS OF ETHICON INC. products (BLAKE Silicone Drain)1. 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: COLLEAGUE INFUSION PUMPS1. Letter from MDB 2. Letter from Baxter

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: MULTIPLE LOTS OF ETHICON INC. products:1.  BLAKE Silicone Drains2.  BLAKE Silicone Drain Kits3.  BLAKE Cardio Connectors4.  J-VAC Reservoirs5.  J-VAC Drain Adapters 1. 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: ALCOHOL PREP PADS MANUFACTURED BY TRIAD GROUP CO-PACKAGED WITH MEDTRONIC EXTERNAL NASAL SPLINTS1. 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.

RECALL: ALL UNIMPLANTED Cochlear Nucleus CI500 cochlear implant range.1. Letter from MDB 2. Letter from Cochlear Limited

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: DePuy Spine Confidence  Introducer Needles 1. Letter from MDB 2. Johnson & Johnson Letter 1 3. Johnson & Johnson Letter 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: VICRYL RAPIDE SUTURES1. Letter from MDB 2. Letter from Johnson & Johnson Sdn. Bhd.

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 Model 990018 Multi-Channel RF Ablation GENius Generator Software Version 111. 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.

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

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 : KYPHX HV-R BONE CEMENT 1. Recall Letter from MDB 2. Recall Letter from Medtronic International Ltd.