Data Foundry

Medical device recalls 2021

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number:… — Class II medical device recall Z-0379-2022

Ongoing recall by Olympus Corporation of the Americas, reported 2021-12-22, distributed nationwide. Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due

Recall numberZ-0379-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmOlympus Corporation of the Americas, Center Valley, PA, United States
Recall initiated2021-11-02
Classified2021-12-10
Reported by FDA2021-12-22
DistributedNationwide (US)
Quantity14,447 units
UPC / GTIN / UDI-DI04953170339967
Serial numbers04953170339967
Model numbersTJF-Q180V

Product

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Reason for recall

Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0379-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.