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

Recall Z-0645-2024 — OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdo

U.S. FDA — Device Enforcement · United States · 2023-11-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0645-2024
Date of alert: 2023-11-20
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): 04953170310386

Reported risk: Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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