The list below contains Medical Device Recalls for the month of January 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 JANUARY 2024 (126 KB)

Date Received

Reference No.

Recall Type

Product Name

Product Registration

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

09/01/2024

  pdf MDA/Recall/P0234-84890215-2024 (835 KB)

Voluntary Recall

PK INSTRUMENTS

GC34084617018

Class II

A05: Mechanical Problem

OLYMPUS (MALAYSIA) SDN. BHD.

MDA-2218-WDP121

16/01/2024

  pdf MDA/Recall/P0235-17535027-2024 (966 KB)

Voluntary Recall

SUPRASORB® A + AG

GD6355223-124001

Class III

A02: Manufacturing, Packaging or Shipping Problem

NYPRAX BUSINESS SOLUTIONS

MDA-5323-WDP123

26/01/2024

  pdf MDA/Recall/P0236-57177993-2024 (503 KB)

Voluntary Recall

DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM

GD29959666618

Class I

A23: Use of Device 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.