Home / Recalls / Olympus Corporation of the Americas / Z-0064-2026

Z-0064-2026 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
1 unit US; 5,286 units OUS

Product Description

BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

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-TE2; UDI: 4953170339998; 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)