Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-2661-2023)

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 : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)

Product Classification:

Class II

Date Initiated: August 10, 2023

Date Posted: October 11, 2023

Recall Number: Z-2661-2023

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: 9961 units

Code Information:

Model-UDI: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" 00815686021122; INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx 00815686021146; INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx 00815686021139; INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx (includes INS-5029) 00815686020736. 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