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

Recall Z-1353-2026 — Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

U.S. FDA — Device Enforcement · United States · 2026-01-16 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1353-2026
Date of alert: 2026-01-16
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Olympus Corporation of the Americas
Product category: device
Product type: Devices

Reported risk: Issue with software algorithm which may lead to overpressure events.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

Recall Z-1353-2026 — Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

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