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Nasopore Firm Nasal Dressing (Stryker) – Packaging Seal Issue (2025)

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Moderate

FDAFeb 25, 2025Nationwide• Stryker Corporation

Zenition 70 (Philips) – Radiation Emission Risk (2025)

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

High

FDAFeb 25, 2025Nationwide• Philips North America Llc

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Nasopore Firm Nasal Dressing (Stryker) – Packaging Seal Issue (2025)

Zenition 70 (Philips) – Radiation Emission Risk (2025)

COR Disposable Kit (DePuy Mitek) – Missing Graft Loader Pin (2025)

Checkpoint Guardian Lead (Checkpoint Surgical) – Adhesive Encapsulation Fault (2025)

COR Disposable Kit (DePuy Mitek) – Missing Pin (2025)

Medline Convenience Kits (Medline) – Tube Recall Issue (2025)

Boppli Bedside Device Kit (PYRAMES) – Noise Detection Issue (2025)

Medline Procedure Kits (Medline) – Cannula Concern (2025)

Medline Procedure Kits (Medline) – Male Luer Material Issue (2025)

IVX Station Transfer Set (Omnicell) – Premature Deployment (2025)

Helix Elite SARS-CoV-2 Standard (Microbiologics) – Cell Target Delay (2025)

Helix Elite Influenza Standard (Microbiologics) – RSV Target Issue (2025)

BD Connecta Luer-Lok (Unknown) – Instruction Mismatch (2025)

Orthofix Pillar SA Spacer (Orthofix) – Mislabeled Height (2025)

Centricity Radiology RA600 (GE Healthcare) – Security Vulnerability (2025)

Centricity Universal Viewer (GE Healthcare) – Security Vulnerability (2025)

MIM Radiological Software (MIM Software) – Image Fusion Error (2025)

Merge Cardio (Merge Healthcare) – Measurement Workflow Issue (2025)

Centricity PACS-IW (GE Healthcare) – Security Vulnerability (2025)

Wayson Hydrocolloid (Medline) – Sterility Compromise (2025)