MEDICAL DEVICE RECALL LISTING APRIL 2023

The list below contains Medical Device Recall for the month of April 2023. These list provides recall reporting information to MDA by establishment in accordance to requirement stipulated in Section 42, Act 737 and Regulation 7 and 8 of 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 Malaysia market. 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 its affected person of its defectiveness or potential defectiveness.

If you have experienced any safety and performance issue 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 2023 

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
06/04/2023	MDA/Recall/P0142-26605188-2023	Voluntary Recall	HOYA VIVINEX TORIC PRELOADED INTRAOCULAR LENS	GC372051170718	Class II	A26: Insufficient Information	MEDFRAY MEDICAL SDN. BHD.	MDA-3605-WDP122
11/04/2023	MDA/Recall/P0146-18665945-2023	Voluntary Recall	HYDRASYS 2	IVDB53611300018	Class I	A02: Manufacturing, Packaging or Shipping Problem	UTAS MAJU SDN. BHD.	MDA-0974-WDP120
18/04/2023	MDA/Recall/P0150-50911713-2023	Voluntary Recall	EVIS EXERA III DUODENOVIDEOSCOPE TJF-Q190V	GB4632321-70352	Class II	A22: Human-Device Interface Problem	OLYMPUS (MALAYSIA) SDN. BHD.	MDA-2218-WDP121

* 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.