Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-2664-2023)

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 Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm INS-0050 vPad Patient Tracker, 5/Bx INS-0048 vPad Connector Cable

Product Classification:

Class II

Date Initiated: August 10, 2023

Date Posted: October 11, 2023

Recall Number: Z-2664-2023

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: 60102 units

Code Information:

INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX 00815686020613; INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx 00815686020590; INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx 00815686020576; INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx 00815686020538; INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" 00815686020538; INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC 00815686020477; INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm 00815686020446; INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm 00815686020439; INS-0050 vPad Patient Tracker, 5/Bx 00815686020408; INS-0048 vPad Connector Cable 00815686020392; 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