RecallRadar

FDA Device recall Z-1274-2022

Colonovideoscope Model CF-H180AL

On 2022-06-29 the FDA classified a Class II recall of Colonovideoscope Model CF-H180AL by Olympus, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1274-2022
ClassificationClass II
Statusterminated
Initiated2022-04-22
Published2022-06-29
Last updated2026-09-13 11:56 UTC
CompanyOlympus
DistributionUS

Product

Colonovideoscope Model CF-H180AL

Reason

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

Identifiers

code_infoUDI-DI: 04953170339615 Serial number: 2501131

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1274-2022%22

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