DAVINCI UROLOGY. Medical convenience kit.

FDA device recall Z-2245-2025 · posted 2025-08-04 · Open, Classified

Recall details

Recalling firm

AVID Medical, Inc.

Reason for recall

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

Action taken

Consignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to complaints@owens-minor.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LRO

Quantity affected

166 units

Distribution

Domestic: CA, IL, MD, OH, PA, TX, WA.

Date initiated

2025-06-11

Date posted

2025-08-04

Location

Toano, VA