Recall archive / FDA device enforcement
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical inte... — FDA record Z-2262-2023
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 May 15, 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
- Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352
- Reason
- Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1816.2 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2262-2023
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 | UDI-DI: 00815686020538 Lot Numbers: 04865230201 and below |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) to 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
- Aug 9, 2023
- Recall initiation date
- May 15, 2023
- Center classification date
- Jul 28, 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.