MEDICAL DEVICE RECALL LISTING FEBRUARY 2025

The list below contains Medical Device Recalls for the month of February 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 FEBRUARY 2025.pdf

No.	Date Received	Reference Number	Recall Type	Product Name	Product Registration Number	Recall Class	Reason for Recall	Recalling Establishment	Establishment License
1.	04/02/2025	MDA/Recall/P0361-82066130-2025	Voluntary Recall	UNIFLOW COAXIAL BREATHING SYSTEMS	GB447531163118	Class II: Moderate Risk	A12: Connection Problem	INTERSURGICAL SDN BHD	MDA-5088-WDP123
2.	04/02/2025	MDA/Recall/P0363-37699536-2025	Voluntary Recall	PIPELINE VANTAGE EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY	GD8603721-68288	Class I: High Risk	A23: Use of Device Problem	MEDTRONIC MALAYSIA SDN BHD	MDA-4793-WDP123
3.	06/02/2025	MDA/Recall/P0364-37080000-2025	Voluntary Recall	MĪAR™ AORTIC ROOT CANNULA	GB8326523-125097	Class III :Low Risk	A02: Manufacturing, Packaging or Shipping Problem
4.	06/02/2025	MDA/Recall/P0365-80908849-2025	Voluntary Recall	DLP® AORTIC ROOT CANNULA	GB5806223-125793	Class III :Low Risk	A02: Manufacturing, Packaging or Shipping Problem
5.	17/02/2025	MDA/Recall/P0366-97884014-2025	Voluntary Recall	AESCULAP ORTHOPILOT® SYSTEM	GB91243575018	Class III :Low Risk	A04: Material Integrity Problem	B. BRAUN MEDICAL INDUSTRIES SDN. BHD.	MDA-4250-W123
6.	20/02/2025	MDA/Recall/P0368-61499460-2025	Voluntary Recall	TB STAINS AND REAGENTS	IVDB19407246518	Class III :Low Risk	A02: Manufacturing, Packaging or Shipping Problem	BECTON DICKINSON SDN BHD	MDA-5083-W123
7.	24/02/2025	MDA/Recall/P0369-68831920-2025	Voluntary Recall	PERICARDIAL SUCKER	GB630391339119	Class II :Moderate Risk	A02: Manufacturing, Packaging or Shipping Problem	NUFA AWANA SDN BHD	MDA-3974-W122

* 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.