MEDICAL DEVICE RECALL LISTING AUGUST 2025
The list below contains Medical Device Recalls for the month of August 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 AUGUST 2025
|
No. |
Date Received |
Reference Number |
Recall Type |
Product Name |
Product Registration Number |
Recall Class |
Reason of Recall |
Recalling Establishment |
Establishment License |
|
1. |
15/08/2025 |
Voluntary Recall |
ENDOTRACHEAL TUBES SYSTEM |
GB6823123-143999 |
Class I :High Risk |
A01: Patient Device Interaction Problem |
VENTICARE MEDICAL (M) SDN BHD |
MDA-5498-K124 |
|
|
2. |
01/08/2025 |
Voluntary Recall |
NEEDLE HOLDER |
GMD56025205417A |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
BECTON DICKINSON SDN BHD |
MDA-5083-W123 |
|
|
3. |
05/08/2025 |
Voluntary Recall |
ENCORE 26 INFLATION DEVICE |
GA3949581516 |
Class III :Low Risk |
A04: Material Integrity Problem |
BOSTON SCIENTIFIC (MALAYSIA) SDN BHD |
MDA-5810-WD124 |
|
|
4. |
08/08/2025 |
Voluntary Recall |
CONSTELLATION VISION SYSTEM |
GC96073327017 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
ALCON LABORATORIES (M) SDN. BHD. |
MDA-5021-W123 |
|
|
5. |
12/08/2025 |
Voluntary Recall |
Sterile Syringe |
GA10626625-193082 |
Class II :Moderate Risk |
A09: Output Problem |
ADVENTA HEALTHCARE SDN. BHD. |
MDA-5667-WDP124 |
|
|
6. |
13/08/2025 |
Voluntary Recall |
HINOTORI SURGICAL ROBOT SYSTEM |
GC8683624-179851 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
SYSMEX (MALAYSIA) SDN. BHD. |
MDA-4997-WDP123 |
|
|
7. |
14/08/2025 |
Voluntary Recall |
VIZISHOT 2 FLEX SINGLE USE ASPIRATION NEEDLE |
GB78398709818 |
Class II :Moderate Risk |
A05: Mechanical Problem |
OLYMPUS (MALAYSIA) SDN. BHD. |
MDA-2218-WDP121 |
|
|
8. |
18/08/2025 |
Voluntary Recall |
STRATAFIX SPIRAL PDS PLUS KNOTLESS TISSUE CONTROL DEVICE |
GD2913522-110161 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
JOHNSON & JOHNSON SDN BHD |
MDA-4880-WDP123 |
|
|
9. |
20/08/2025 |
Voluntary Recall |
DLP® LEFT HEART VENT CATHETER |
GB2414723-125057 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
MEDTRONIC MALAYSIA SDN BHD |
MDA-4793-WDP123 |
|
|
10. |
20/08/2025 |
Voluntary Recall |
AESCULAP POWER SYSTEM |
GB68825829018 |
Class I :High Risk |
A21: Labelling, Instructions for Use or Training Problem |
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
MDA-4298-K123 |
|
|
11. |
29/08/2025 |
Voluntary Recall |
INSTRUMENTS |
GC48560748218 |
Class I :High Risk |
A04: Material Integrity 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.
