MEDICAL DEVICE RECALL LISTING SEPTEMBER 2025
The list below contains Medical Device Recalls for the month of September 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 SEPTEMBER 2025
|
No. |
Date Received |
Reference Number |
Recall Type |
Product Name |
Product Registration Number |
Recall Class |
Reason of Recall |
Recalling Establishment |
Establishment License |
|
1. |
30/09/2025 |
Establishment (Voluntary Recall) |
QUO-LAB A1C SYSTEM |
IVDB8128921-67256 |
A02: Manufacturing, Packaging or Shipping Problem |
Class II: Moderate Risk |
UBISSON SDN BHD |
MDA-5314-W123 |
|
|
2. |
11/09/2025 |
Establishment (Voluntary Recall) |
SAMARITAN PAD 350P/360P/500P |
GC1448998616 |
A02: Manufacturing, Packaging or Shipping Problem |
Class III: Low Risk |
MURSMEDIC MALAYSIA SDN. BHD. |
MDA-5600-W124 |
|
|
3. |
05/09/2025 |
Establishment (Voluntary Recall) |
EURODEFIPADS |
GC10719224-185696 |
A02: Manufacturing, Packaging or Shipping Problem |
Class II: Moderate Risk |
JUST NU MEDICARE SDN BHD |
MDA-5938-WDP124 |
|
|
4. |
10/09/2025 |
Establishment (Voluntary Recall) |
COBAS® HCV |
IVDD3403524-176110 |
A02: Manufacturing, Packaging or Shipping Problem |
Class III: Low Risk |
ROCHE DIAGNOSTICS (M) SDN. BHD. |
MDA-5585-WDP124 |
|
|
5. |
11/09/2025 |
Establishment (Voluntary Recall) |
CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY |
IVDC19194190418 |
A04: Material Integrity Problem |
Class III: Low Risk |
ROCHE DIAGNOSTICS (M) SDN. BHD. |
MDA-5585-WDP124 |
|
|
6. |
14/09/2025 |
Establishment (Voluntary Recall) |
STA® - LIATEST® D-DI PLUS |
IVDC5347522-90795 |
A04: Material Integrity Problem |
Class III: Low Risk |
ALL EIGHTS (M) SDN BHD |
MDA-4259-WDP123 |
|
|
7. |
25/09/2025 |
Establishment (Voluntary Recall) |
SIGNIA SMALL DIAMETER RELOADS |
GD9181722-85855 |
A27: Appropriate Term/Code Not Available |
Class III: Low Risk |
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.
