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.
pdf MEDICAL DEVICE RECALL LISTING JULY 2023 (129 KB)
|
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.
