Official recall record

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

US FDA — Medical Devices · 2023-09-22 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-09-22
Country of alert: United States
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 04953170324147
Brand on record: Olympus Corporation of the Americas

What the authority reported

There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2023-09-25 · US FDA — Medical Devices
Insufflation unit, UHI-4.
2026-06-16 · US FDA — Medical Devices
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Other recalls from this brand

All 21 official recall notices naming Olympus Corporation of the Americas on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.