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

EVIS EXERA III Gastrointestinal Videoscope

FDA Recall Z-0288-2024 · Posted 2023-11-09

Recall StatusOpen, Classified
Product CodeFDF
Date Initiated2023-10-02
Product Quantity1687 units

Reason for Recall

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

Firm Action

The firm distributed recall notifications via mail to consignees dated 10/02/2023. Consignees are asked to inspect inventory for affected devices, ensure that all reprocessing personnel are aware and knowledgeable of the recall notice and its contents, and acknowledge receipt of the recall notification by returning the enclosed response form via email to [email protected] or by fax at 800-913-4345. Customers with any questions about the acknowledgement form are to call 866-912-9544. Customers with any questions about the recall are to contact Cynthia Ow by phone at 647-999-3203 or by email at [email protected].

Root Cause

Reprocessing Controls

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

↑