Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

GYN ROBOTIC PACK. Medical convenience kit.

FDA Recall Z-2251-2025 · Posted 2025-08-04

Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeOKV
Date Initiated2025-06-11
Product Quantity45 units

Reason for Recall

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

Firm Action

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 [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑