MEDICAL DEVICE RECALL LISTING JULY 2023

The list below contains Medical Device Recall for the month of July 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 JULY 2023

Date Received	Reference No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
04/07/2023	MDA/Recall/P0183-98610616-2023	Voluntary Recall	POWERSPIRAL	GB5498322-96108	Class II	A27: Appropriate Term/Code Not Available	OLYMPUS (MALAYSIA) SDN. BHD.	MDA-2218-WDP121
10/07/2023	MDA/Recall/P0184-81141062-2023	Voluntary Recall	ACROBAT SUV VACUUM OFF-PUMP SYSTEM	GB3806023-134469	Class II	A17: Compatibility Problem	RBD HEALTHCARE SDN BHD	MDA-4488-WDP123
13/07/2023	MDA/Recall/P0185-35263762-2023	Voluntary Recall	COBAS X 480 INSTRUMENT	IVDA87215200918	Class III	A23: Use of Device Problem	ROCHE DIAGNOSTICS (M) SDN. BHD.	MDA-1674-WDP121
14/07/2023	MDA/Recall/P0187-62671494-2023	Voluntary Recall	BenchMark	IVDA7917823-115778	Class III	A23: Use of Device Problem	ROCHE DIAGNOSTICS (M) SDN. BHD.	MDA-1674-WDP121
14/07/2023	MDA/Recall/P0188-89730954-2023	Voluntary Recall	KARL STORZ SINGLE-USE FLEXIBLE INTUBATION VIDEO ENDOSCOPE	GB5838321-52999	Class I	A02: Manufacturing, Packaging or Shipping Problem	UMMI SURGICAL SDN BHD	MDA-4833-WDP123
24/07/2023	MDA/Recall/P0190-39405912-2023	Voluntary Recall	SINGLE USE SYRINGES, 2-PIECE	GA1919740916	Class III	A02: Manufacturing, Packaging or Shipping Problem	B. BRAUN MEDICAL INDUSTRIES SDN. BHD.	MDA-4250-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.