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Palindrome Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)

Potential breach of sterile barrier packaging.

FDAApr 23, 2025Nationwide• Mozarc Medical US LLC

MIRA Surgical System (Virtual Incision) – Motion Interruption (2025)

The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.

High

FDAApr 23, 2025CA, FL, NE• VIRTUAL INCISION CORPORATION

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Palindrome Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)

MIRA Surgical System (Virtual Incision) – Motion Interruption (2025)

Palindrome Precision Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)

Apo B Reagent (Beckman Coulter) – Calibration Error (2025)

DxI 9000 Access Analyzer (Beckman Coulter) – Software Update Error (2025)

Palindrome Precision H Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)

Mahurkar Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)

Endopath Echelon Vascular Reload (Ethicon) – Instrument Lockout (2025)

Plum Solos Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Codman Disposable Perforator Kit (Medline) – Weld Inadequacy (2025)

Catalyst+ C4D Software (C-RAD) – Scanning Equipment Error (2025)

3M Ranger Irrigation Set (3M) – Flow Rate Clarification (2025)

Plum Duo Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Lower Extremity Implant (American Contract) – EO/ECH Residuals (2025)

BIB Balloon Catheter (Numed) – Labeling Error (2025)

BD Cathena IV Catheter (BD) – Septum Defect Risk (2025)

Precision Sampling Set (Capnia) – Contamination Risk (2025)

Bard Intragastric Balloon Tube (C.R. Bard) – Plug Removal (2025)

Bard Minnesota Tamponade Tube (C.R. Bard) – Plug Removal (2025)

Straumann Healing Abutment (Straumann) – Blister Labeling (2025)