MEDICAL DEVICE RECALL LISTING JANUARY 2025

The list below contains Medical Device Recalls for the month of January 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 JANUARY 2025.pdf

No	Date Received	Reference Number	Recall Type	Product Name	Product Registration	Recall Class	Reason for Recall	Recalling Establishment	Establishment License
1	03/01/2025	MDA/Recall/P0299-16637967-2024	Voluntary Recall	ACROBAT-I VACUUM STABILIZER SYSTEM	GB3805023-133245	Class II: Moderate Risk	A17: Compatibility Problem	RBD HEALTHCARE SDN BHD	MDA-4488-WDP123
2	09/01/2025	MDA/Recall/P0357-66712436-2025	Voluntary Recall	ZIMMER NEXGEN COMPLETE KNEE SOLUTION LEGACY CONSTRAINED CONDYLAR KNEE (LCCK) SYSTEM	GC85953379417	Class III: Low Risk	A05: Mechanical Problem	ZIMMER MALAYSIA (MALAYSIA) SDN BHD	MDA-6538-WDP124
3	13/01/2025	MDA/Recall/P0359-67093794-2025	Voluntary Recall	PRELOADED INTRAOCULAR LENS	GC2656025716	Class III: Low Risk	A02: Manufacturing, Packaging or Shipping Problem	CARL ZEISS SDN BHD	MDA-4561-W123

* 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.