Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush Recalled by Olympus Corporation of the Americas Due to Electromagnetic (EM) sensor tracking malfunction impacts the use...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-5300
Quantity: 759.8 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report