MEDICAL DEVICE RECALL LISTING MAY 2025
The list below contains Medical Device Recalls for the month of May 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 LISTING MAY 2O25
|
No. |
Date Received |
Reference Number |
Recall Type |
Product Name |
Product Registration Number |
Recall Class |
Reason for Recall |
Recalling Establishment |
Establishment Licence |
|
1. |
02/05/2025 |
Establishment (Voluntary Recall) |
THE BELMONT HYPERTHERMIA PUMP |
GC89158618618 |
Class III: Low Risk |
A02: Manufacturing, Packaging or Shipping Problem |
TRANSMEDIC HEALTHCARE SDN BHD |
MDA-4762-WDP123 |
|
|
2. |
05/05/2025 |
Establishment(Voluntary Recall) |
CONSTELLATION VISION SYSTEM |
GC96073327017 |
Class II: Moderate Rsik |
A02: Manufacturing, Packaging or Shipping Problem |
ALCON LABORATORIES (M) SDN. BHD. |
MDA-5021-W123 |
|
|
3. |
19/05/2025 |
Establishment (Voluntary Recall) |
ARTHREX LATERAL SHOULDER POSITIONERS |
GA3588823-156337 |
Class III :Low Risk |
A02: Manufacturing, Packaging or Shipping Problem |
TRANSMEDIC HEALTHCARE SDN BHD |
MDA-4762-WDP123 |
|
|
4. |
21/05/2025 |
Establishment (Voluntary Recall) |
ROBOTIC ARM INTERACTIVE ORTHOPAEDIC SYSTEM (RIO) |
GC593731188118 |
Class III :Low Risk |
A04: Material Integrity Problem |
STRYKER CORPORATION (MALAYSIA) SDN. BHD. |
MDA-5657-WDP124 |
|
|
5. |
23/05/2025 |
Establishment (Voluntary Recall) |
SUSCEPTIBILITY AND IDENTIFICATION TEST FOR MYCOBACTERIA |
IVDC23724200218 |
Class II :Moderate Risk |
A23: Use of Device Problem |
BECTON DICKINSON SDN BHD |
MDA-5083-W123 |
|
|
6. |
23/05/2025 |
Establishment (Voluntary Recall) |
ALINITY I TOTAL PSA |
IVDC86110274518 |
Class II :Moderate Risk |
A09: Output Problem |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
MDA-5104-W123 |
|
|
7. |
23/05/2025 |
Establishment (Voluntary Recall) |
STA® - NEOPTIMAL |
IVDC6519023-137999 |
Class III :Low Risk |
A27: Appropriate Term/Code Not Available |
ALL EIGHTS (M) SDN BHD |
MDA-4259-WDP123 |
|
|
8. |
26/05/2025 |
Establishment (Voluntary Recall) |
ARTERIAL PERFUSION CANNULA |
GD7681622-82736 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
EDWARDS LIFESCIENCES (MALAYSIA) SDN BHD |
MDA-4697-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.
