Data Foundry

Medical device recalls 2022

Colonovideoscope Model CF-H180AL — Class II medical device recall Z-1274-2022

Terminated recall by Olympus Corporation of the Americas, reported 2022-06-29, distributed nationwide. A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, vi

Recall numberZ-1274-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmOlympus Corporation of the Americas, Center Valley, PA, United States
Recall initiated2022-04-22
Classified2022-06-21
Reported by FDA2022-06-29
Terminated2024-03-13
DistributedNationwide (US)
Quantity1 units
UPC / GTIN / UDI-DI04953170339615
Serial numbers2501131
Model numbersCF-H180AL

Product

Colonovideoscope Model CF-H180AL

Reason for recall

A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding

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-1274-2022. 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.