Urgent Field Safety Notice For High Flow Insufflation Unit - Uhi-4 By Olympus Medical Systems Corp.

Recall Summary Olympus Medical Systems Corp. has issued an urgent field safety notice for the HIGH FLOW INSUFFLATION UNIT - UHI-4, a Class I medical device distributed in Germany and the EU. The notice indicates a potential safety issue with this equipment, though specific details about the risk are not provided in the available information. This recall affects medical facilities and users of this insufflation unit in the affected regions.

Recalling firm

Urgent Field Safety Notice for HIGH FLOW INSUFFLATION UNIT - UHI-4 by Olympus Medical Systems Corp. , Download_Veroeffen

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for HIGH FLOW INSUFFLATION UNIT - UHI-4 by Olympus Medical Systems Corp

Reason

assessment Field corrective actions Urgent Field Safety Notice for HIGH FLOW INSUFFLATION UNIT - UHI-4 by Olympus Medical Systems Corp

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-06-25

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/aff935ee-4618-4757-bf3f-f7da4db400aa