The list below contains Medical Device Recall for the month of June 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.

  MEDICAL DEVICE RECALL LISTING JUNE 2023

Date Received

Reference No.

Recall Type

Product Name

Product Registration

Recall Class

Reason of Recall

Recalling Establishment

Establishment License

01/06/2023

MDA/Recall/P0171-13423663-2023

Voluntary Recall

VERITAS VISION SYSTEM

GC2538221-71446

Class III

A26: Insufficient Information

JOHNSON & JOHNSON SDN BHD

MDA-4880-WDP123

02/06/2023

MDA/Recall/P0170-25517312-2023

Voluntary Recall

PATIENT CONNECTIONS

GB491791268519

Class II

A02: Manufacturing, Packaging or Shipping Problem

KL MED SUPPLIES (M) SDN BHD

MDA-2434-WDP121

14/06/2023

MDA/Recall/P0176-61388126-2023

Voluntary Recall

ROTATING SPINE POSITIONERS

GA9655122-88079

Class II

A23: Use of Device Problem

WELCH ALLYN MALAYSIA SDN BHD

MDA-310-W21615

29/06/2023

MDA/Recall/P0182-83668044-2023

Voluntary Recall

MAHURKAR ACUTE DUAL AND TRIPLE LUMEN CATHETER KIT

GD10956523-131786

Class I

A02: Manufacturing, Packaging or Shipping Problem

MEDTRONIC MALAYSIA SDN BHD

MDA-4793-WDP123

* 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