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MEDICAL DEVICE RECALL LISTING MARCH 2025
The list below contains Medical Device Recalls for the month of March 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 FOR MARCH 2025
|
No |
Date Received |
Reference Number |
Recall Type |
Product Name |
Product Registration Number |
Recall Class |
Reason for Recall |
Recalling Establishment |
Establishment License |
|
1. |
05/03/2025 |
Establishment (Voluntary Recall) |
STRYKER NASOPORE® DRESSING |
GB32300907918 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
EASMED SDN BHD |
MDA-5343-WDP123 |
|
|
2. |
07/03/2025 |
MDA/Recall/P0373-45944801-2025 |
Establishment (Voluntary Recall) |
ZIMMER NEXGEN COMPLETE KNEE SOLUTION, LPS, LPS-FLEX SYSTEM |
GC72096673118 |
Class III :Low Risk |
A21: Labelling, Instructions for Use or Training Problem |
ZIMMER MEDICAL (MALAYSIA) SDN BHD |
MDA-6538-WDP124 |
|
3. |
13/03/2025 |
Establishment (Voluntary Recall) |
SYNCHROMED II PROGRAMMABLE PUMP SYSTEM AND ACCESSORIES |
GD6185822-96376 |
Class II :Moderate Risk |
A27: Appropriate Term/Code Not Available |
MEDTRONIC MALAYSIA SDN BHD |
MDA-4793-WDP123 |
|
|
4. |
13/03/2025 |
Establishment (Voluntary Recall) |
SYNCHROMED III PROGRAMMABLE PUMP SYSTEM AND ACCESSORIES |
GD5639524-177237 |
Class II :Moderate Risk |
A27: Appropriate Term/Code Not Available |
MEDTRONIC MALAYSIA SDN BHD |
MDA-4793-WDP123 |
|
|
5. |
18/03/2025 |
Establishment (Voluntary Recall) |
AMPLATZER TORQVUE DELIVERY SYSTEMS |
GD37981609818 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
MDA-4705-WDP123 |
|
|
6. |
21/03/2025 |
Establishment (Voluntary Recall) |
HAEMODIALYSIS CONCENTRATES |
GC16566384017 |
Class I :High Risk |
A18: Contamination / decontamination Problem |
FRESENIUS MEDICAL CARE PRODUCTION SDN. BHD. |
MDA-4760-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.
