MEDICAL DEVICE RECALL LISTING APRIL 2026

The list below contains Medical Device Recalls for the month of April 2026. 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 2026

No.	Date Received	Reference Number	Recall Type	Product Name	Product Registration Number	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
1.	03/04/2026	MDA/Recall/P0521-59732809-2026	Establishment (Voluntary Recall)	TENOR	GA6312419-29083	Class II: Moderate Risk	A02: Manufacturing, Packaging or Shipping Problem	BEST CONTACT (M) SDN BHD	MDA-5525-WDP124
2.	02/04/2026	MDA/Recall/P0524-40215251-2026	Establishment (Voluntary Recall)	ZIMMER BONE CEMENT ACCESSORIES	GB619831022718	Class III: Low Risk	A02: Manufacturing, Packaging or Shipping Problem	ZIMMER MEDICAL (MALAYSIA) SDN BHD	MDA-6538-WDP124
3.	06/04/2026	MDA/Recall/P0525-72702643-2026	Establishment (Voluntary Recall)	SYRINGE	GB6979824-157861	Class III: Low Risk	A23: Use of Device Problem	H&A MEDICAL SUPPLY SDN BHD	MDA-6010-WDP124
4.	13/04/2026	MDA/Recall/P0527-66202214-2026	Establishment (Voluntary Recall)	INZONE DETACHMENT SYSTEM	GC54327161017	Class II: Moderate Risk	A07: Electrical /Electronic Property Problem	STRYKER CORPORATION (MALAYSIA) SDN. BHD.	MDA-5657-WDP124
5.	22/04/2026	MDA/Recall/P0530-34168771-2026	Establishment (Voluntary Recall)	DLP® RETROGRADE CORONARY SINUS PERFUSION CANNULA	GB2266423-128554	Class II: Moderate Risk	A02: Manufacturing, Packaging or Shipping Problem	MEDTRONIC MALAYSIA SDN BHD	MDA-4793-WDP123
6.	28/04/2026	MDA/Recall/P0533-16589695-2026	Establishment (Voluntary Recall)	GENTEAL LUBRICANT EYE DROPS	GB35237660118	Class II: Moderate Risk	A02: Manufacturing, Packaging or Shipping Problem	ALCON LABORATORIES (M) SDN. BHD.	MDA-5021-W123
7.	28/04/2026	MDA/Recall/P0534-75693836-2026	Establishment (Voluntary Recall)	GENTEAL LUBRICANT EYE GEL	GB67890515817	Class II: Moderate Risk	A02: Manufacturing, Packaging or Shipping Problem	ALCON LABORATORIES (M) SDN. BHD.	MDA-5021-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.