Home / Recalls / Olympus Corporation of the Americas / Z-1353-2026

Z-1353-2026 Class I Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
February 25, 2026
Initiation Date
January 16, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
744 units

Product Description

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.

Reason for Recall

Issue with software algorithm which may lead to overpressure events.

Distribution Pattern

Nationwide distribution

Code Information

Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers

Other recalls by Olympus Corporation of the Americas

  • Z-1489-2026 Class II — Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per bo (January 29, 2026)
  • Z-1488-2026 Class II — Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box (January 29, 2026)
  • Z-1354-2026 Class I — Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflat (January 16, 2026)
  • Z-1352-2026 Class I — Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflatio (January 16, 2026)
  • Z-1494-2026 Class II — Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Nam (January 8, 2026)
  • Z-1290-2026 Class II — Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411 (January 7, 2026)
  • Z-1273-2026 Class II — Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41 (January 7, 2026)
  • Z-1296-2026 Class II — Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411 (January 7, 2026)
  • Z-1277-2026 Class II — Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca (January 7, 2026)
  • Z-1286-2026 Class II — Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4 (January 7, 2026)