MEDICAL DEVICE RECALL LISTING JANUARY 2026

The list below contains Medical Device Recalls for the month of January 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 JANUARY 2026

No.	Date Received	Reference Number	Recall Type	Product Name	Product Registration Number	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
1.	13/01/2026	MDA/Recall/P0476-79011959-2026	Establishment (Voluntary Recall)	VIZISHOT 2 FLEX SINGLE USE ASPIRATION NEEDLE	GB78398709818	Class II :Moderate Risk	A05: Mechanical Problem	OLYMPUS (MALAYSIA) SDN. BHD.	MDA-2218-WDP121
2.	13/01/2026	MDA/Recall/P0478-41002997-2026	Establishment (Voluntary Recall)	HIGH FREQUENCY SPHINCTEROTOME	GC726531024218	Class II :Moderate Risk	A05: Mechanical Problem	OLYMPUS (MALAYSIA) SDN. BHD.	MDA-2218-WDP121
3.	19/01/2026	MDA/Recall/P0479-76694841-2026	Establishment (Voluntary Recall)	DA VINCI SI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS3000	GC74543334017	Class II :Moderate Risk	A27: Appropriate Term/Code Not Available	DTG MEDICAL SDN BHD	MDA-4091-WDP122
4.	19/01/2026	MDA/Recall/P0480-11682079-2026	Establishment (Voluntary Recall)	DA VINCI SI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS3000	GC74543334017	Class II :Moderate Risk	A27: Appropriate Term/Code Not Available	DTG MEDICAL SDN BHD	MDA-4091-WDP122
5.	15/01/2026	MDA/Recall/P0481-25326490-2026	Establishment (Voluntary Recall)	HICKMAN CENTRAL VENOUS CATHETERS	GD78617561018	Class II :Moderate Risk	A02: Manufacturing, Packaging or Shipping Problem	BECTON DICKINSON SDN BHD	MDA-5083-W123
6.	15/01/2026	MDA/Recall/P0482-88125165-2026	Establishment (Voluntary Recall)	BROVIAC CENTRAL VENOUS CATHETER	GD6710123-133101	Class II :Moderate Risk	A02: Manufacturing, Packaging or Shipping Problem	BECTON DICKINSON SDN BHD	MDA-5083-W123
7.	19/01/2026	MDA/Recall/P0483-15942341-2026	Establishment (Voluntary Recall)	DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000	GC3810021-64842	Class II :Moderate Risk	A27: Appropriate Term/Code Not Available	DTG MEDICAL SDN BHD	MDA-4091-WDP122
8.	19/01/2026	MDA/Recall/P0484-95973794-2026	Establishment (Voluntary Recall)	DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000	GC3810021-64842	Class II :Moderate Risk	A27: Appropriate Term/Code Not Available	DTG MEDICAL SDN BHD	MDA-4091-WDP122
9.	27/01/2026	MDA/Recall/P0488-52812230-2026	Establishment (Voluntary Recall)	AQUASIL PUTTY IMPRESSION MATERIAL	GMD61708268217A	Class III :Low Risk	A25: No Apparent Adverse Event	DENTSPLY SIRONA MALAYSIA SDN. BHD.	MDA-4163-WDP122

* 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.