MEDICAL DEVICE RECALL LISTING JULY 2025
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 |
Voluntary Recall |
NASOGEL TUBE |
GB5801523-154871 |
Class III |
A02: Manufacturing, Packaging or Shipping Problem |
JETPHARMA SDN BHD |
MDA-5334-WDP123 |
|
2. |
08/07/2025 |
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 |
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 |
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.