Home / Recalls / Olympus Corporation of the Americas / Z-0189-2024

Z-0189-2024 Class I Ongoing

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

Recall Details

Product Type
Devices
Report Date
November 15, 2023
Initiation Date
October 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15942 devices

Product Description

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160

Reason for Recall

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

Distribution Pattern

US Nationwide distribution

Code Information

Model BF-1T150 UDI-DI: 4953170308185; Model BF-1T60 UDI-DI: 4953170339264; Model BF-P150 UDI-DI: N/A; Model BF-P60 UDI-DI: 4953170339196; Model BF-XT160 UDI-DI: N/A

Other recalls by Olympus Corporation of the Americas

  • Z-1694-2026 Class II — Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLT (February 27, 2026)
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  • Z-1639-2026 Class II — Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product N (February 25, 2026)
  • Z-1638-2026 Class II — Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: E (February 25, 2026)
  • Z-1640-2026 Class II — Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Force (February 25, 2026)
  • Z-1644-2026 Class II — Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For (February 25, 2026)
  • Z-1641-2026 Class II — Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS C (February 25, 2026)
  • Z-1642-2026 Class II — Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For (February 25, 2026)
  • Z-1643-2026 Class II — Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutt (February 25, 2026)
  • Z-1612-2026 Class II — Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. (February 12, 2026)