FDA Medical Device Recalls (openFDA)
Covidien LLC: Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.
- Recall number
- Z-1125-2017
- Recalling firm
- Covidien LLC
- Product
- Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.
- Status
- Terminated
- Initiated
- 2016-12-16
- Posted
- not on file
- Terminated
- 2018-12-04
- Reason
- Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
- Root cause
- Process control
- Action
- Medtronic initiated on December 16, 2016. Customers were notified via Federal Express and the letter instructed customers to discontinue use of the product and return all inventory to Medtronic (Covidien) 195 McDermott Road, North Haven, CT 06473 Attn: Field Returns Department. Complete a Recalled Product Return Form (Attachment A, included with letter) and submit it to customer service so a Returned Goods Authorization number (RGA#) can be issued. Questions contact Medtronic representative or customer service at 800-882-5878.
- Quantity
- 7453 Units
- Distribution
- Nationwide. Foreign: Belgium Germany France Netherlands
- Lot, serial or model codes
- Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
- 510(k) numbers
- ["K904039"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- 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