| 1 |
2026-09-04 |
MDA/Recall/P0550-68169656-2026 |
Establishment (Voluntary Recall) |
NDI PASSIVE SPHERES |
GMD43188570818A |
Class II :Moderate Risk |
A08: Calibration Problem |
MEDTRONIC MALAYSIA SDN BHD |
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|
| 2 |
2026-08-26 |
MDA/Recall/P0548-24312385-2026 |
Establishment (Voluntary Recall) |
DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000 |
GC3810021-64842 |
Class II :Moderate Risk |
A27: Appropriate Term/Code Not Available |
DTG MEDICAL SDN BHD |
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|
| 3 |
2026-08-12 |
MDA/Recall/P0547-15827738-2026 |
Establishment (Voluntary Recall) |
CONFIRM™ ANTI-ALK1 (ALK01) PRIMARY ANTIBODY |
IVDC10803623-151207 |
Class III :Low Risk |
A02: Manufacturing, Packaging or Shipping Problem |
ROCHE DIAGNOSTICS (M) SDN. BHD. |
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|
| 4 |
2026-08-10 |
MDA/Recall/P0544-21470823-2026 |
Establishment (Voluntary Recall) |
BICOAG HEMOSTASIS PROBE |
GC68151232317 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
OLYMPUS (MALAYSIA) SDN. BHD. |
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|
| 5 |
2026-08-10 |
MDA/Recall/P0546-89366368-2026 |
Establishment (Voluntary Recall) |
cobas 5800 |
IVDA4563422-99323 |
Class III :Low Risk |
A02: Manufacturing, Packaging or Shipping Problem |
ROCHE DIAGNOSTICS (M) SDN. BHD. |
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|
| 6 |
2026-07-16 |
MDA/Recall/P0540-75730025-2026 |
Establishment (Voluntary Recall) |
HIGH PRESSURE MANIFOLDS |
GB16901151617 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
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|
| 7 |
2026-07-16 |
MDA/Recall/P0541-15752981-2026 |
Establishment (Voluntary Recall) |
SAMARITAN PAD 350P/360P/500P |
GC1448998616 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
MURSMEDIC MALAYSIA SDN. BHD. |
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|
| 8 |
2026-07-02 |
MDA/Recall/P0539-65468458-2026 |
Establishment (Voluntary Recall) |
3M COMPLY STEAM INDICATOR TAPES |
GMD44234837018A |
Class III :Low Risk |
A02: Manufacturing, Packaging or Shipping Problem |
SOLVENTUM MALAYSIA SDN. BHD. |
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|
| 9 |
2026-05-14 |
MDA/Recall/P0537-92802550-2026 |
Establishment (Voluntary Recall) |
OCTOPUS® EVOLUTION TISSUE STABILIZER |
GB7449122-101379 |
Class I :High Risk |
A02: Manufacturing, Packaging or Shipping Problem |
MEDTRONIC MALAYSIA SDN BHD |
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|
| 10 |
2026-04-22 |
MDA/Recall/P0530-34168771-2026 |
Establishment (Voluntary Recall) |
DLP® RETROGRADE CORONARY SINUS PERFUSION CANNULA |
GB2266423-128554 |
Class II :Moderate Risk |
A02: Manufacturing, Packaging or Shipping Problem |
MEDTRONIC MALAYSIA SDN BHD |
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|