Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1375-2024 — Insufflation unit, UHI-4.

U.S. FDA — Device Enforcement · United States · 2023-09-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1375-2024
Date of alert
2023-09-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170324147
Reported risk: Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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