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Inflow/Bifurcated Outflow Line Kit (Belmont) – Connector Crack Risk (2025)

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

Moderate

FDAMar 31, 2025Nationwide• Belmont Instrument LLC

Guide Wire with Ruler Tube (Stryker) – Metal Ring Detachment Risk (2025)

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

Moderate

FDAMar 28, 2025Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

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Inflow/Bifurcated Outflow Line Kit (Belmont) – Connector Crack Risk (2025)

Guide Wire with Ruler Tube (Stryker) – Metal Ring Detachment Risk (2025)

Guide Wire with Ruler Tube (Stryker) – Metal Ring Detachment Risk (2025)

Introducer Needle (Galt Medical) – Sterile Packaging Seal (2025)

B Braun Coaxial Dilator (Galt Medical) – Sterile Packaging Seal (2025)

B Braun Elite HV Hemostasis Valve (Galt Medical) – Sterile Packaging Seal (2025)

Introducer Tearaway MicroSlide (Galt Medical) – Sterile Packaging Seal (2025)

Introducer Kit Coaxial Dilator (Galt Medical) – Sterile Packaging Seal (2025)

enVista Monofocal IOL (Bausch & Lomb) – Toxic Segment Syndrome (2025)

Galt Centeze Catheter (Galt Medical) – Sterile Packaging Seal (2025)

Galt Guidewire (Galt Medical) – Sterile Packaging Seal (2025)

DxI 9000 Access Immunoassay Analyzer (Beckman Coulter) – Host System Connectivity (2025)

enVista Envy IOL (Bausch & Lomb) – Toxic Segment Syndrome (2025)

Skytron Freedom Monitor Mount (IHB Operations) – Mounting Hardware Risk (2025)

Trimble RTS873 Robotic Station (Trimble) – Laser Output Power (2025)

Restor3d Cordera Hip System (Conformis) – Incorrect Liner Labeling (2025)

Intera 3.0T Quasar Dual (Philips) – Coil Seal Adhesive Failure (2025)

IceSeed 1.5 CX S Needle US (Boston Scientific) – Demo Settings Issue (2025)

Intera 1.5T (Philips) – Coil Seal Adhesive Failure (2025)

SmartPath to dStream (Philips) – Coil Seal Adhesive Failure (2025)