Covidien Nellcor SpO2 Forehead Sensor Recalled for Latex Labeling Error
FDA is recalling 7,453 units of the Covidien Nellcor SpO2 Forehead Sensor because the label incorrectly states the product is latex-free, while the headband contains latex.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling (latex) on a medical device, which fits the rubric criteria for a High severity score (3) as it presents a risk of harm to sensitive individuals, though no specific injuries are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien Nellcor SpO2 Forehead Sensor, model RS10. The recall involves 7,453 units distributed nationwide and in Belgium, Germany, France, and the Netherlands. The specific lot numbers affected are 161510095H, 161620089H, 161690203H, 161760132H, 161900091H, 161970090H, 162040107H, 162110103H, 162320191H, and 162390212H.
The recall is due to a labeling error. The product label indicates that the sensor is latex-free; however, the headband component included with the forehead sensor does contain latex. This discrepancy poses a risk to patients with latex allergies who may be exposed to the material during use.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or the manufacturer, Covidien LLC, in accordance with the recall instructions.
The recalled product
- 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.
- Manufacturer
- Covidien LLC
- Affected units
- 7,453
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot Numbers: 161510095H
- 161620089H
- 161690203H
- 161760132H
- 161900091H
- 161970090H
- 162040107H
- 162110103H
- 162320191H
- 162390212H
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · latex allergy
See all →- ModerateDJO Nylatex Wraps Recalled for Missing Latex Warning Labels
FDA (Devices) · 2020-07-22
- HighCustom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
FDA (Devices) · 2020-02-05
- ModerateMerit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
FDA (Devices) · 2019-10-09
- HighCardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex
FDA (Devices) · 2019-05-15
- HighCardinal Health Recalls ChemoPlus Goggles Due to Latex Mislabeling
FDA (Devices) · 2019-05-15