Recall Z-2243-2025— AVID Medical, Inc.

Name: FDA recall Z-2243-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-11

Class II · Ongoing

Class II FDA medical device recall by AVID Medical, Inc., initiated 2025-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: DA VINCI PACK URO/PROSTATE. Medical convenience kit.. Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration..

Recalling firm: AVID Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-11
Firm location: Toano, VA, United States

Product description

DA VINCI PACK URO/PROSTATE. Medical convenience kit.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.