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Karl Storz Aggressive Cutter (Karl Storz) – Sterility Barrier Breach (2024)

Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

FDAOct 11, 2024Nationwide• Karl Storz Endoscopy

Boston Scientific SmartFreeze Cryo Console (Boston Scientific) – Use Instructions (2024)

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Moderate

FDAOct 10, 2024Nationwide• Boston Scientific Corporation

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Karl Storz Aggressive Cutter (Karl Storz) – Sterility Barrier Breach (2024)

Boston Scientific SmartFreeze Cryo Console (Boston Scientific) – Use Instructions (2024)

BioZorb Marker (Hologic) – Adverse Event Risk (2024)

Boston Scientific POLARx Balloon Catheter (Boston Scientific) – Use Instructions (2024)

Vue PACS Viewer (Philips) – Calculation Errors (2024)

Boston Scientific POLARx Balloon Catheter (Boston Scientific) – Use Instructions (2024)

Imed Products Imed EVA Bag 1000 mL (The Metrix Company) – IV Bag Leak Risk (2024)

SECURE 500 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

Vygon 250mL EVA Container (Metrix) – IV Bag Leak (2024)

Vygon 100mL EVA Container (Metrix) – IV Bag Leak (2024)

SECURE 100 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

CORMIX 500 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

MEDLINE Medical Convenience Kits (MEDLINE) – Smoke Evacuation Pencil Issue (2024)

CORMIX 250 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

Imed Products Imed EVA Bag 250 mL (The Metrix Company) – IV Bag Leak Risk (2024)

MEDLINE Convenience Kits (MEDLINE) – Smoke Evacuation Pencil Issue (2024)

Autosampler SIL-40C Models (Unknown) – Main Board Condensation Failure (2024)

Imed Products Imed EVA Bag 500 mL (The Metrix Company) – IV Bag Leak Risk (2024)

Imed Products Imed EVA Bag 150 mL (The Metrix Company) – IV Bag Leak Risk (2024)

SECURE 250 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)