The list below contains Medical Device Recalls for the month of March 2024. This list provides recall reporting information to the Malaysian Medical Device Authority (MDA) by establishments in accordance with the requirements stipulated in Section 42, Act 737, and Regulations 7 and 8 of the Medical Device (Duties and Obligations of Establishment) Regulations 2019.

Recall is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysian market. A recall is any action taken by the establishment of the medical device to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied, and to notify affected persons of its defectiveness or potential defectiveness.

If you have experienced any safety or performance issues with one of the medical devices listed for recall action, please seek advice from your healthcare professional as soon as possible.

  pdf MEDICAL DEVICE RECALL LISTING MARCH 2024   (138 KB)

Date Received

Reference No.

Recall Type

Product Name

Product Registration

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

16/03/2024

  pdf MDA/Recall/P0248-76933609-2024 (552 KB)

Voluntary Recall

CLEARVIEW® INTRACORONARY SHUNT

GB2174023-125091

Class II

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

16/03/2024

  pdf MDA/Recall/P0249-39416580-2024 (552 KB)

Voluntary Recall

MC2® TWO STAGE VENOUS CANNULA

GB2190423-128552

Class II

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

16/03/2024

 

  pdf MDA/Recall/P0250-42161663-2024 (552 KB)

Voluntary Recall

DLP® SINGLE STAGE VENOUS CANNULA

GB2321923-125105

Class II

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

16/03/2024

  pdf MDA/Recall/P0251-10714053-2024 (552 KB)

Voluntary Recall

DLP® LEFT HEART VENT CATHETER

GB2414723-125057

Class II

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

16/03/2024

  pdf MDA/Recall/P0252-38526905-2024 (552 KB)

Voluntary Recall

DLP® ONE-PIECE PEDIATRIC ARTERIAL CANNULA

GB5559423-128558

Class II

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

16/03/2024

  pdf MDA/Recall/P0253-53959033-2024 (552 KB)

Voluntary Recall

DLP® CARDIAC SUCTION TUBE

GB6549023-127517

Class II

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

16/03/2024

 

  pdf MDA/Recall/P0254-30232634-202 (552 KB) 4

Voluntary Recall

DLP® SINGLE STAGE VENOUS CANNULA

GB6879723-129857

Class II

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

16/03/2024

  pdf MDA/Recall/P0255-29355891-2024 (552 KB)

Voluntary Recall

VC2™ ATRIAL CAVAL VENOUS CANNULA

GB8384823-129855

Class II

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

20/03/2024

  pdf MDA/Recall/P0256-16071109-2024 (151 KB)

Voluntary Recall

KLARO™ IN VIVO SURGICAL LIGHTING

GB6647721-65910

Class II

A02: Manufacturing, Packaging or Shipping Problem

GOODMAN PLT.

MDA-3604-WDP122

25/03/2024

  pdf MDA/Recall/P0258-42286569-2024 (494 KB)

Voluntary Recall

GRAFTON™ DBM

GD9615023-127511

Class III

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

* The information contained in the Medical Device Authority Recall database is released under Regulation 7(8) and Regulation 8 (5) of Malaysia’s Medical Device Regulations 2019