FDA Medical Device Recalls (openFDA)
Nihon Kohden America Inc: Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
- Recall number
- Z-0268-2025
- Recalling firm
- Nihon Kohden America Inc
- Product
- Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
- Status
- Open, Classified
- Initiated
- 2024-09-18
- Posted
- 2024-10-30
- Terminated
- not on file
- Reason
- Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
- 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 vitalsignsTS@nihonkohden.com. 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 vitalsignsTS@nihonkohden.com.
- Quantity
- 64
- 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
- Lot, serial or model codes
- Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 2080783
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28