Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1....

FDA Device Recall #Z-2265-2023 — Class II — May 15, 2023

Recall Summary

Recall Number Z-2265-2023
Classification Class II — Moderate risk
Date Initiated May 15, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Olympus Corporation of the Americas
Location Center Valley, PA
Product Type Devices
Quantity 526.4 units

Product Description

Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 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-0382

Reason for Recall

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

Distribution Pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.

Lot / Code Information

UDI-DI: 00815686020590 Lot Numbers: 04992210324 and below

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.