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Showing 981–1000 of 8389 results

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

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

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

Da Vinci Urology Kit (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.

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

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

Low

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

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

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

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

HVI Cardiac Robot Pack (AVID Medical) – Visualization System Error (2025)

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

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

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

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

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

Gen Laparoscopy 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.

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

Devices had an unapproved slabbing software function enabled for use.

FDAJun 11, 2025Nationwide• FUJIFILM Healthcare Americas Corporation

LAVH 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.

General Laparoscopy Tray (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.

Cardiac Robot 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.

Endosee Convenience Kit (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.

FDAJun 11, 2025Nationwide• CooperSurgical, Inc.

General Robotic 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.

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

Out of specification stability test result for the Caphosol B solution from process validation lots

FDAJun 11, 2025Nationwide• RECORDATI RARE DISEASES INC.

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

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

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

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

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

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

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

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

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

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

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

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

CT Da Vinci Kit (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.

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

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

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

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