Z-1125-2017Class II

Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10...

Name: Z-1125-2017 Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10...
Creator: Covidien LLC
Published: 2016-12-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-12-16 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive... on 2016-12-16. FDA classified it as Class II and gives the reason as "Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1125-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Posted: 2017-02-02
Terminated: 2018-12-04
Recalling firm: Medtronic, Inc.
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.
Product code: DQA Oximeter
Reason for recall: Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Root cause tag: manufacturing process
FDA 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 in commerce: 7453 Units
Distribution: Nationwide. Foreign: Belgium Germany France Netherlands
Product codes and lots: Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1125-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1125-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-02-02

Product code DQA

K904039Class IIReflectance Sensor (Rs-10)Nellcor, Inc. / cleared 1990-12-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)