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 |
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 |
Voluntary Recall |
COBAS 5800 |
IVDA4563422-99323 |
Class III |
A02: Manufacturing, Packaging or Shipping Problem |
COBAS 5800 |
IVDA4563422-99323 |
|
|
3. |
12/08/2026 |
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 |
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 |
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.