Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-2660-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes INS-5700 SPiN EWC Biopsy Guide Kit

Product Classification:

Class II

Date Initiated: August 10, 2023

Date Posted: October 11, 2023

Recall Number: Z-2660-2023

Event ID: 92893

Reason for Recall:

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

Status: Ongoing

Product Quantity: 6484 units

Code Information:

Model- UDI: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes 00815686021313; INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes 00815686021306; INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021290; INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes 00815686021276; INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021269; INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes 00815686021153; INS-5700 SPiN EWC Biopsy Guide Kit 00815686021108. All serial numbers and all lot numbers

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Voluntary or Mandated:

Voluntary: Firm initiated