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Paparrela-Type Vent Tube (Olympus) – Expiration Date Missing (2023)

The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot

Moderate

FDADec 11, 2023Nationwide• Olympus Corporation of the Americas

Flow-c Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

Laceration Risk

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

High

FDADec 11, 2023Nationwide• Getinge Usa Sales Inc

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Paparrela-Type Vent Tube (Olympus) – Expiration Date Missing (2023)

Flow-c Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

Cranial Drill 2.40mm (Globus) – Sterility Packaging Concern (2023)

Flow-i C20 Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

Flow-i C40 Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

Cranial Drill 6.00mm (Globus) – Sterility Packaging Concern (2023)

BrainFeedback Pro 2 Device (Ronan) – Performance Documentation Issue (2023)

Flow-e Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

ENDOPATH Echelon Reloads (Ethicon) – Staple Line Formation Risk (2023)

Flow-i C30 Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

WAVi Research EEG System (WAVi) – Research Study Closure (2023)

Duodenovideoscope Distal Cover (Olympus) – Detachment Risk (2023)

XScribe Cardiac Stress System (Baxter) – ECG Reading Distortion (2023)

Mega Soft Universal Plus Electrode (Megadyne) – Burn Injury Risk (2023)

Azurion FlexArm System (Philips) – Connectivity Loss (2023)

XScribe Cardiac Testing System (Baxter) – ECG Reading Distortion (2023)

Mega Soft Universal Plus Electrode (Megadyne) – Burn Injury Risk (2023)

Mega Soft Universal Electrode (Megadyne) – Burn Injury Risk (2023)

Mega Soft Universal Electrode (Megadyne) – Burn Injury Risk (2023)

Q-Stress Cardiac System (Baxter) – ECG Reading Distortion (2023)