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

Recall Z-1275-2022 — EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

U.S. FDA — Device Enforcement · United States · 2022-04-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1275-2022
Date of alert
2022-04-22
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)
04953170305276
Reported risk: Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
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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