Home / Recalls / Olympus Corporation of the Americas / Z-0053-2026

Z-0053-2026 Class I Ongoing

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

Recall Details

Product Type
Devices
Report Date
October 22, 2025
Initiation Date
September 11, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,221 units US; 4,321 units OUS

Product Description

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

Reason for Recall

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Distribution Pattern

US Nationwide Distribution.

Code Information

Model No. BF-H190; UDI: 4953170335174; All Serial No.

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-1352-2026 Class I — Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflatio (January 16, 2026)
  • Z-1354-2026 Class I — Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflat (January 16, 2026)
  • Z-1353-2026 Class I — Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuffla (January 16, 2026)
  • Z-1494-2026 Class II — Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Nam (January 8, 2026)
  • Z-1292-2026 Class II — Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411 (January 7, 2026)
  • Z-1270-2026 Class II — Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4 (January 7, 2026)
  • Z-1288-2026 Class II — Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4 (January 7, 2026)
  • Z-1271-2026 Class II — Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41 (January 7, 2026)