No | Date received | Reference No | Recall Type | Product Name | Product Registration | Recall Class | Reason of Recall | Recalling Establishment | Recall Notice |
---|---|---|---|---|---|---|---|---|---|
1 | 2025-05-05 | MDA/Recall/P0396-20208974-2025 | Establishment (Voluntary Recall) | CONSTELLATION VISION SYSTEM | GC96073327017 | Class II :Moderate Risk | A02: Manufacturing, Packaging or Shipping Problem | ALCON LABORATORIES (M) SDN. BHD. |
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2 | 2025-04-25 | MDA/Recall/P0390-38191321-2025 | Establishment (Voluntary Recall) | TORNADO EMBOLIZATION COILS AND MICROCOILS | GD34698117417 | Class II :Moderate Risk | A02: Manufacturing, Packaging or Shipping Problem | COOK ASIA (MALAYSIA) SDN BHD |
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3 | 2025-04-16 | MDA/Recall/P0385-64232512-2025 | Establishment (Voluntary Recall) | CODMAN DISPOSABLE PERFORATOR | GB52719760018 | Class I :High Risk | A05: Mechanical Problem | SCHMIDT BIOMEDTECH SDN BHD |
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4 | 2025-03-13 | MDA/Recall/P0375-73290050-2025 | Establishment (Voluntary Recall) | SYNCHROMED II PROGRAMMABLE PUMP SYSTEM AND ACCESSORIES | GD6185822-96376 | Class II :Moderate Risk | A27: Appropriate Term/Code Not Available | MEDTRONIC MALAYSIA SDN BHD |
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5 | 2025-03-13 | MDA/Recall/P0376-27856062-2025 | Establishment (Voluntary Recall) | SYNCHROMED III PROGRAMMABLE PUMP SYSTEM AND ACCESSORIES | GD5639524-177237 | Class II :Moderate Risk | A27: Appropriate Term/Code Not Available | MEDTRONIC MALAYSIA SDN BHD |
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6 | 2025-03-05 | MDA/Recall/P0372-56309887-2025 | Establishment (Voluntary Recall) | STRYKER NASOPORE® DRESSING | GB32300907918 | Class II :Moderate Risk | A02: Manufacturing, Packaging or Shipping Problem | EASMED SDN BHD |
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7 | 2025-02-20 | MDA/Recall/P0368-61499460-2025 | Establishment (Voluntary Recall) | TB STAINS AND REAGENTS | IVDB19407246518 | Class III :Low Risk | A02: Manufacturing, Packaging or Shipping Problem | BECTON DICKINSON SDN BHD |
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8 | 2025-02-06 | MDA/Recall/P0364-37080000-2025 | Establishment (Voluntary Recall) | MĪAR™ AORTIC ROOT CANNULA | GB8326523-125097 | Class III :Low Risk | A02: Manufacturing, Packaging or Shipping Problem | MEDTRONIC MALAYSIA SDN BHD |
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9 | 2025-02-06 | MDA/Recall/P0365-80908849-2025 | Establishment (Voluntary Recall) | DLP® AORTIC ROOT CANNULA | GB5806223-125793 | Class III :Low Risk | A02: Manufacturing, Packaging or Shipping Problem | MEDTRONIC MALAYSIA SDN BHD |
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10 | 2025-02-04 | MDA/Recall/P0363-37699536-2025 | Establishment (Voluntary Recall) | PIPELINE VANTAGE EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY | GD8603721-68288 | Class I :High Risk | A23: Use of Device Problem | MEDTRONIC MALAYSIA SDN BHD |
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