Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nihon Kohden America Inc
- Reason for Recall:
- Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Product Codes/Lot Numbers:
Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0267-2025
Related Recalls
Due to products being shipped/distributed to customers after the products expiration date had past.
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Nihon Kohden America
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Due to software issue the device may give false "SpO2 Probe Failure" alarm