| 1 |
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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|
| 2 |
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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|
| 3 |
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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|
| 4 |
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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|
| 5 |
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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|
| 6 |
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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|
| 7 |
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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|
| 8 |
2024-12-18 |
MDA/Recall/P0354-13401169-2024 |
Establishment (Voluntary Recall) |
MECHANICAL LITHOTRIPTOR |
GA65102107116 |
Class II :Moderate Risk |
A04: Material Integrity Problem |
OLYMPUS (MALAYSIA) SDN. BHD. |
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|
| 9 |
2024-12-05 |
MDA/Recall/P0350-82624946-2024 |
Establishment (Voluntary Recall) |
STEALTHSTATION S7 TREATMENT GUIDANCE SYSTEM (SPINAL) |
GD2205223-131802 |
Class II :Moderate Risk |
A23: Use of Device Problem |
MEDTRONIC MALAYSIA SDN BHD |
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|
| 10 |
2024-11-11 |
MDA/Recall/P0347-99297066-2024 |
Establishment (Voluntary Recall) |
BD BBL™ SENSI-DISC™ SUSCEPTIBILITY TEST DISCS |
IVDB6578123-148932 |
Class II :Moderate Risk |
A23: Use of Device Problem |
BECTON DICKINSON SDN BHD |
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|