Z-0267-2025Class II

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

Name: Z-0267-2025 Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe...
Creator: Nihon Kohden America Inc
Published: 2024-09-18
License: https://open.fda.gov/license/

Nihon Kohden America Inc / initiated 2024-09-18 / Open, Classified

FDA source

Nihon Kohden America Inc began a recall of Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box on 2024-09-18. FDA classified it as Class II and gives the reason as "Due to oximeters not having FDA market approval or clearance to distribute in the U.S". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0267-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-18
Posted: 2024-10-30
Recalling firm: Nihon Kohden America Inc
Product: Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Product code: DQA Oximeter
Reason for recall: Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
FDA root cause: No Marketing Application
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].
Quantity in commerce: 67
Distribution: 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
Product codes and lots: Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0267-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0267-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30
Z-0268-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30

Product code DQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)