MEDICAL DEVICE RECALL LISTING APRIL 2025

The list below contains Medical Device Recalls for the month of April 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 APRIL 2025.pdf

No.	Date Received	Reference Number	Recall Type	Product Name	Product Registration Number	Recall Class	Reason for Recall	Recalling Establishment	Establishment Licence
1.	09/04/2025	MDA/Recall/P0383-73149245-2025	Establishment (Voluntary Recall)	ON-X ASCENDING AORTIC PROSTHESIS AND ON-X HEART VALVE INSTRUMENTS	GD8557723-147098	Class III :Low Risk	A02: Manufacturing, Packaging or Shipping Problem	MEDI-LIFE (M) SDN. BHD.	MDA-4741-WDP123
2.	16/04/2025	MDA/Recall/P0385-64232512-2025	Establishment (Voluntary Recall)	CODMAN DISPOSABLE PERFORATOR	GB52719760018	Class I :High Risk	A05: Mechanical Problem	SCHMIDT BIOMEDTECH SDN BHD	MDA-5076-WDP123
3.	16/04/2025	MDA/Recall/P0384-18438503-2025	Establishment (Voluntary Recall)	TUFTEX EMBOLECTOMY CATHETERS	GB2580023-125507	Class II :Moderate Risk	A02: Manufacturing, Packaging or Shipping Problem	ANDAMAN MEDICAL BRIDGE SDN. BHD.	MDA-5221-W123
4.	16/04/2025	MDA/Recall/P0386-42568042-2025	Establishment (Voluntary Recall)	PRUITT OCCLUSION CATHETER	GB2509622-104128
5.	16/04/2025	MDA/Recall/P0387-59432765-2025	Establishment (Voluntary Recall)	PRUITT IRRIGATION OCCLUSION CATHETER	GB2128122-101561
6.	18/04/2025	MDA/Recall/P0388-64500684-2025	Establishment (Voluntary Recall)	HINOTORI SURGICAL ROBOT SYSTEM	GC8683624-179851	Class II :Moderate Risk	A04: Material Integrity Problem	SYSMEX (MALAYSIA) SDN. BHD.	MDA-4997-WDP123
7.	25/04/2025	MDA/Recall/P0390-38191321-2025	Establishment (Voluntary Recall)	TORNADO EMBOLIZATION COILS AND MICROCOILS	GD34698117417	Class II :Moderate Risk	A02: Manufacturing, Packaging or Shipping Problem	COOK ASIA (MALAYSIA) SDN BHD	MDA-5123-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.