Home / Recalls / Olympus Corporation of the Americas / Z-2263-2023

Z-2263-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
August 9, 2023
Initiation Date
May 15, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
254.4 units

Product Description

Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0362

Reason for Recall

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

Distribution Pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.

Code Information

UDI-DI: 00815686020552 Lot Numbers: 05010210512 and below

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)
  • Z-1695-2026 Class II — Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE (February 27, 2026)
  • 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)