The list below contains Medical Device Recalls for the month of August 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 AUGUST 2026

No.

Date Received

Reference Number

Recall Type

Product Name

Product Registration

Number

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

1.

10/08/2026

 MDA/Recall/P0544-21470823-2026

Voluntary Recall

BICOAG HEMOSTASIS PROBE

GC68151232317

Class II

A02: Manufacturing, Packaging or Shipping Problem

OLYMPUS (MALAYSIA) SDN. BHD.

MDA-2218-WDP121

2.

10/08/2026

 MDA/Recall/P0546-89366368-2026

Voluntary Recall

COBAS 5800

IVDA4563422-99323

Class III

A02: Manufacturing, Packaging or Shipping Problem

COBAS 5800

IVDA4563422-99323

3.

12/08/2026

 MDA/Recall/P0547-15827738-2026

Voluntary Recall

CONFIRM™ ANTI-ALK1 (ALK01) PRIMARY ANTIBODY

IVDC10803623-151207

Class III: Low Risk

A02: Manufacturing, Packaging or Shipping Problem

CONFIRM™ ANTI-ALK1 (ALK01) PRIMARY ANTIBODY

IVDC10803623-151207

4.

26/08/2026

 MDA/Recall/P0548-24312385-2026

Voluntary Recall

DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000

GC3810021-64842

Class II

A27: Appropriate Term/Code Not Available

DTG MEDICAL SDN BHD

MDA-4091-WDP122

5.

26/08/2026

 MDA/Recall/P0549-25780413-2026

Voluntary Recall

DA VINCI SI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS3000

GC74543334017

Class II

A27: Appropriate Term/Code Not Available

DTG MEDICAL SDN BHD

MDA-4091-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.