The list below contains Medical Device Recalls for the month of July 2025. 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.

MEDICAL DEVICE RECALL LISTING JULY 2025

No.

Date Received

Reference Number

Recall Type

Product Name

Product Registration

Number

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

1.

24/01/2025

MDA/Recall/P0415-39645057-2025

Voluntary Recall

NASOGEL TUBE

GB5801523-154871

Class III

A02: Manufacturing, Packaging or Shipping Problem

JETPHARMA SDN BHD

MDA-5334-WDP123

2.

08/07/2025

MDA/Recall/P0419-30602785-2025

Voluntary Recall

CAROTID WALLSTENT MONORAIL

GD94941309717

Class III

A23: Use of Device Problem

BOSTON SCIENTIFIC (MALAYSIA) SDN BHD

MDA-5810-WD124

3.

16/07/2025

 MDA/Recall/P0422-69098658-2025

Voluntary Recall

VENCLOSE RADIOFREQUENCY SYSTEM

GC5750923-148658

Class II

A07: Electrical /Electronic Property Problem

BECTON DICKINSON SDN BHD

MDA-5083-W123

4.

24/07/2025

MDA/Recall/P0425-41063047-2025

Voluntary Recall

CELSITE® IMPLANTABLE VASCULAR ACCESS SYSTEMS AND ACCESSORIES

GD59669269417

Class III

A15: Activation, Positioning or Separation Problem

B. BRAUN MEDICAL INDUSTRIES SDN. BHD.

MDA-4298-K123

* 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.