Recall archive / FDA device enforcement
Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access ... — FDA record Z-2660-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 6484 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2660-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 11, 2023
- Recall initiation date
- Aug 10, 2023
- Center classification date
- Sep 29, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.