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MEDICAL DEVICE RECALL LISTING MAY 2024
The list below contains Medical Device Recalls for the month of May 2024. 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.
pdf MEDICAL DEVICE RECALL LISTING MAY 2024 (132 KB)
|
Date Received |
Reference No. |
Recall Type |
Product Name |
Product Registration |
Recall Class |
Reason of Recall |
Recalling Establishment |
Establishment License |
|
06/05/2024 |
Voluntary Recall |
HUMIDIFIER MYAIRVO2 |
GB197511053618 |
Class II |
A07: Electrical /Electronic Property Problem |
EMERGO MALAYSIA SDN. BHD. |
MDA-5078-W123 |
|
|
08/05/2024 |
Voluntary Recall |
LAPAROSCOPY SYSTEM |
GB26809989718 |
Class III |
A27: Appropriate Term/Code Not Available (require revision_ |
OLYMPUS (MALAYSIA) SDN. BHD. |
MDA-2218-WDP121 |
|
|
14/05/2024
|
Voluntary Recall |
TACTOSET INJECTABLE BONE SUBSTITUTE SYSTEM |
GD5361723-124925 |
Class II |
A25: No Apparent Adverse Event |
CIMED HEALTHCARE SDN. BHD. |
MDA-3498-W122 |
|
|
15/05/2024 |
Voluntary Recall |
PDS™ II (POLYDIOXANONE) STERILE SYNTHETIC, ABSORBABLE SUTURE |
GD4349722-103519 |
Class III |
A02: Manufacturing, Packaging or Shipping Problem |
JOHNSON & JOHNSON SDN BHD. |
MDA-4880-WDP123 |
|
|
15/05/2024 |
Voluntary Recall |
CASCADE IOMAX |
GC5241323-144670 |
Class III |
A02: Manufacturing, Packaging or Shipping Problem |
T T MEDICAL MANAGEMENT SDN. BHD. |
MDA-2373-W121 |
* 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.
