FDA Device recall Z-2660-2023
Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree fo…
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree fo… by Olympus, citing non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufactu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2660-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-10 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
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
Reason
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
Identifiers
| code_info | Model- UDI: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes 00815686021313; INS-5920 SPiN Access…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2660-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.