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Partial Nephrectomy Pack (Avid Medical) – Visualization System Discoloration (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

HSG Procedure Tray (CooperSurgical) – Iodine Pouch Labeling (2025)

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

Moderate

FDAJun 11, 2025Nationwide• CooperSurgical, Inc.

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Partial Nephrectomy Pack (Avid Medical) – Visualization System Discoloration (2025)

HSG Procedure Tray (CooperSurgical) – Iodine Pouch Labeling (2025)

Robotic Uro/GYN Pack (AVID Medical) – Visualization System Error (2025)

Laparoscopy Pack (AVID Medical) – Visualization System Error (2025)

Rivian R1S (Rivian) – Turn Signal Malfunction (2025)

GYN Laparoscopy Pack (AVID Medical) – Visualization System Error (2025)

Laparoscopic Prostatectomy (AVID Medical) – Visualization System Error (2025)

CT Da Vinci Kit (Avid Medical) – Visualization System Discoloration (2025)

Laparoscopic GYN (AVID Medical) – Visualization System Error (2025)

Lap Chole Pack (AVID Medical) – Visualization System Error (2025)

Caphosol Artificial Saliva (Recordati) – Stability Test Concern (2025)

Laparoscopic Tray (Avid Medical) – Visualization System Discoloration (2025)

General Robotic Pack (Avid Medical) – Visualization System Discoloration (2025)

Cardiac Robot Pack (Avid Medical) – Visualization System Discoloration (2025)

Endosee Convenience Kit (CooperSurgical) – Iodine Pouch Labeling (2025)

Asprire Cristalle Mammography (Fujifilm) – Unapproved Software (2025)

General Laparoscopy Tray (Avid Medical) – Visualization System Discoloration (2025)

GYN Robotic Pack (AVID Medical) – Visualization System Error (2025)

Da Vinci Uro/Prostate Pack (Avid Medical) – Visualization System Discoloration (2025)

Major Thoracoscopy Basin (AVID Medical) – Visualization System Error (2025)