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Open, Classified

Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box

FDA Recall Z-0267-2025 · Posted 2024-10-30

Recalling FirmNihon Kohden America Inc
Recall StatusOpen, Classified
Product CodeDQA
Date Initiated2024-09-18
Product Quantity67

Reason for Recall

Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

Firm Action

On 10/07/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" via certified mail or FedEx informing customers that the Sp02 sensor's intended use was not reviewed/evaluated by the FDA and does not have market approval or clearance for distribution in the U.S. Customers are instructed to: 1. Identify any Caremed SpO2 sensor packages you have in inventory and cease use of the affected product. 2. Complete the attached Medical Device Notification Return Response Form 3. Email the completed Medical Device Notification Return Response Form back to NKA Technical Services at [email protected]. Nihon Kohden is requesting all unused stock be returned to Nihon Kohden and a full refund will be issued for unused product. Please contact Nihon Kohden Technical Support to coordinate the return of the affected product. If you have questions about this notification or the form below, please call Nihon Kohden America at 1-800-325-0283, Option 2 (M-F, 8am-5pm PDT) or email [email protected].

Root Cause

No Marketing Application

Distribution Pattern

U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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